510(k) · Cleared
ClearedVitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Apr 24, 2006 as substantially equivalent to K052819 (Ortho-Clinical Diagnostics, Inc., 2005) after an 18-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Apr 24, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904768 (1990). 13 ancestors in all, the oldest K771603 (1977). No later device cites it as a predicate yet.
- Root · 4 generations backK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990 · Recalled
- 3 generations backK041720 Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- 2 generations backK042477 Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- 1 generation backK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
- This deviceK060940 Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | 1990 | 1 |
| −3 | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2004 | 1 |
| −2 | K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| −1 | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| 0 (this device) | K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 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 JIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Summary page 1…d VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use. Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 99, and VrTROS AAT/HPT Perfomance Verifiers 1, 11,and… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K052819.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.
For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060940
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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