510(k) · Cleared
ClearedVitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JIT Calibrator, Secondary
Cleared on Nov 18, 2004 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Nov 18, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K023158 (2002). 4 ancestors in all, the oldest K860894 (1986). No later device cites it as a predicate yet.
- Root · 2 generations backK023158 Randox Apolipoprotein CalibratorRandox Laboratories, Ltd. · 2002
- 1 generation backK041870 N Apolipoprotein Standard SerumDade Behring, Inc. · 2004
- This deviceK042521 Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits…Ortho-Clinical Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| −1 | K041870 | N Apolipoprotein Standard Serum | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K042521 | Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 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 JIT? 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? (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 |
|---|---|---|---|
| * | K860894 | Behring Nephelometer SystemSummary page 3…ROS Chemistry Products Calibrator Kit 21 are substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA fo… | 1986 |
| * | K041870 | N Apolipoprotein Standard SerumSummary page 3…substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA for IVD use.… | 2004 |
| * | K993310 | Apolipoprotein Control Serum CHD, Model OuphSummary page 6…substantially equivalent to the Dade Behring Apolipoprotein Control Serum CHD (predicate device) which was cleared by the FDA (K9933 10) for IVD use. Table 2 lists the similarities and differences of the device characteristics between… | 1999 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 16 other devices also cite its predicate K860894.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products ApoAl Reagent is used to quantitatively measure apolipoprotein AI (ApoA1) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5,1 FS…
Read the full statement (218 words)
For in vitro diagnostic use only. VITROS Chemistry Products ApoAl Reagent is used to quantitatively measure apolipoprotein AI (ApoA1) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein Al (ApoA l).
For in vitro diagnostic use only. VITROS Chemistry Products ApoA I Performance Verifier I is an assayed controls used to monitor the performance of ApoAl Reagent on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB3) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB).
For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042521: Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042521
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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