510(k) · Cleared
Recalled · Class II · 2023VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · PDJ Hemoglobin A1c Test System
Cleared on Jun 4, 2015 as substantially equivalent to DEN130002 (Roche Diagnostics, 2013) and 2 other predicates after a 262-day review. Its family tree reaches back 2 generations to 1990. It has been recalled 2 times.
- Decided
- Jun 4, 2015
- Review
- 262 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904768 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990 · Recalled
- 1 generation backK041764 The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004
- This deviceK142595 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit…Ortho Clinical Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | 1990 | 1 |
| −1 | K041764 | The Vitros 5,1 FS Chemistry System | Ortho-Clinical Diagnostics | 2004 | — |
| 0 (this device) | K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS… | Ortho Clinical Diagnostics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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 PDJ? 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 PDJ device
- #1 K252749 Medconn 8K Glycated Hemoglobin Test Systemscore 11.5 · 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? (3)
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 |
|---|---|---|---|
| * | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
| * | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1CSummary page 5…t to the Roche Tina Quant HbA1c Dx.Gen.2 assay (K121291). The VITROS® Chemistry Products Calibrator Kit 31 is substantially equivalent to the Roche C.f.a.s HbA1c (k052101). The VITROS® Chemistry Products %A1c Performance Verifiers are substantially equivalent to the VITROS® Chemistry Product… | 2005 |
| * | K041764 | The Vitros 5,1 FS Chemistry SystemSummary page 5…emistry Products %A1c Performance Verifiers are substantially equivalent to the VITROS® Chemistry Products %A1c Performance Verifiers that were previously cleared (K041764). 4. Device Description The determination of % glycated hemoglobin (HbA1c) is performed using the VITROS Chemistry Produc… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2023 | Class II | Z-1628-2023 | Under Investigation by firm | Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis |
| Apr 19, 2016 | Class III | Z-2804-2016 | Employee error | There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 6 other devices also cite its predicate DEN130002.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PDJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDJ
203in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDJ
42in 2025
MAUDE reports naming product code PDJ, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 4 | 234 | 0 | 2 |
| 2016 | 2 | — | 1 | 0 |
| 2017 | 3 | 173 | 0 | 1 |
| 2018 | 5 | 203 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 19 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 2 | — | 0 | 42 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use only VITROS Chemistry Products HbA1c reagent is used on VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes…
Read the full statement (178 words)
For in vitro diagnostic use only
VITROS Chemistry Products HbA1c reagent is used on VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood.
The test is to be used as an aid in diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
For in vitro diagnostic use only
VITROS Calibrator Kit 31 is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
For in vitro diagnostic use only
VITROS Chemistry Products %A1c Performance Verifiers are assayed controls used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to monitor performance of the VITROS d%A1c and VITROS HbA1c Reagent Kits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142595: VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142595
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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