510(k) · Cleared
Recalled · Class II · 2019Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Jun 30, 2008 as substantially equivalent to K961099 (Johnson & Johnson Clinical Diagnostics, Inc., 1996) and 1 other predicate after a 41-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 30, 2008
- Review
- 41 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K984303 (1999). 7 ancestors in all, the oldest K800054 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK984303 Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc. · 1999
- 3 generations backK012593 Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros…Ortho-Clinical Diagnostics, Inc. · 2001 · Recalled
- 2 generations backK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 1 generation backK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- This deviceK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See all- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · cites it directly1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984303 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −3 | K012593 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2001 | 1 |
| −2 | K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| −1 | K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| 0 (this device) | K081411 | Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2008 | — |
| +1 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +2 | K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K961099 | Ektachem Clinical Chemistry Slide Sodium (NA+)Summary page 1…ent slide) and VITROS Chemistry Products Calibrator Kit 2. The FDA cleared the VITROS Chemistry Products Na+ Slides on May 7, 1996 (K96 1099) under the product name EKTACHEM Clinical Chemistry Slide Sodium (Nat). With the purchase of KODAK Clinical Pr… | 1996 |
| * | K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2Summary page 1…emistry Products Na+ Slides. The most recent FDA clearance for the VITROS Chemistry Products Calibrator Kit 2 was December 7, 2007 (K073 157). Ortho Clinical Diagnostics, Inc. Special 510(k) VITROS Chemistry Products Na± Slides VITROS Chemistry Products Calibrator K… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model… | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2019 | Class II | Z-0992-2019 | Under Investigation by firm | Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results. |
| Dec 20, 2016 | Class II | Z-1117-2017 | Under Investigation by firm | There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements… |
| Oct 17, 2013 | Class II | Z-1088-2014 | Under Investigation by firm | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. |
| Oct 17, 2013 | Class II | Z-1087-2014 | Under Investigation by firm | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K091861 (Ortho-Clinical Diagnostics, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Na + Slides quantitatively measure sodium (Na +) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance.
For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CY, ECO2, HDLC, K +, Na +, and TRIG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081411: Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081411
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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