510(k) · Cleared
Recalled · Class II · 2025VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JFY Enzymatic Method, Creatinine
Cleared on Oct 30, 2018 as substantially equivalent to K160495 (Ortho-Clinical Diagnostics, Inc., 2016) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled 20 times.
- Decided
- Oct 30, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- JFY
- Recalls
- 20
- Predicates
- 4
Its longest line of descent runs back 2 generations to K001310 (2000). 8 ancestors in all, the oldest K840880 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001310 Vitros Chemistry Products Crea Slide, Virtros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2000
- 1 generation backK063591 Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- This deviceK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001310 | Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2000 | — |
| −1 | K063591 | Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2006 | 2 |
| 0 (this device) | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | — |
| +1 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160495 | VITROS® Automation SolutionsSummary page 5…FDA 510(k) Number 1 VITROS Chemistry VITROS Chemistry k160495 Products CRBM Slides Products CRBM Slides 2 VITROS Chemistry VITROS Chemistry k06359… | 2016 |
| * | K063591 | Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products…Summary page 5…VITROS Chemistry k160495 Products CRBM Slides Products CRBM Slides 2 VITROS Chemistry VITROS Chemistry k063591 Products CREA Slides Products CREA Slides 3 VITROS Chemistry VITROS Chemistry k84088… | 2006 |
| * | K840880 | Ektachem Clinical Chem. SlidesSummary page 5…VITROS Chemistry k063591 Products CREA Slides Products CREA Slides 3 VITROS Chemistry VITROS Chemistry k840880 Products TBIL Slides Products TBIL Slides 4 VITROS XT 7600 VITROS 5600 k08154… | 1984 |
| * | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…Summary page 5…VITROS Chemistry k840880 Products TBIL Slides Products TBIL Slides 4 VITROS XT 7600 VITROS 5600 k081543 Integrated System Integrated System Intended Use Statement(s) 1. VITROS Chemistry Products CRBM Slides Rx Only… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2025 | Class II | Z-2039-2025 | Software design | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during… |
| Dec 19, 2024 | Class II | Z-1006-2025 | Software Design Change | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would… |
| Jan 26, 2024 | Class II | Z-1232-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not… |
| Jan 26, 2024 | Class II | Z-1227-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. |
| Jan 26, 2024 | Class II | Z-1228-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. |
| Jan 26, 2024 | Class II | Z-1233-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not… |
| Jan 22, 2024 | Class II | Z-1222-2024 | Component change control | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results. |
| Oct 10, 2023 | Class II | Z-0546-2024 | Under Investigation by firm | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or… |
| Oct 10, 2023 | Class II | Z-0547-2024 | Under Investigation by firm | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or… |
| Aug 9, 2023 | Class II | Z-0008-2024 | Under Investigation by firm | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification… |
| Mar 10, 2023 | Class II | Z-1555-2023 | Under Investigation by firm | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable |
| Jul 19, 2022 | Class II | Z-1676-2022 | Under Investigation by firm | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists… |
| Jul 19, 2022 | Class II | Z-1675-2022 | Under Investigation by firm | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists… |
| Mar 26, 2021 | Class II | Z-1489-2021 | Under Investigation by firm | Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to… |
| Jul 20, 2020 | Class II | Z-2879-2020 | Process control | When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. |
| Jul 20, 2020 | Class II | Z-2878-2020 | Process control | When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. |
| Jul 13, 2020 | Class II | Z-2873-2020 | Other | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| Mar 20, 2019 | Class II | Z-1364-2019 | Software design | Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported |
| Mar 11, 2019 | Class II | Z-1222-2019 | Software design | One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user. |
| Feb 20, 2019 | Class II | Z-1291-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 11.9 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K190326 (Ortho-Clinical Diagnostics, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
1. VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy. 2. VITROS Chemistry Products CREA Slides: Rx…
Read the full statement (235 words)
1. VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
2. VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
3. VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
4. VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026