510(k) · Cleared
Recalled · 2011Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb 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, Inc. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Nov 18, 2004 as substantially equivalent to K972929 (Behring Diagnostics, Inc., 1997) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1989. It has been recalled once.
- Decided
- Nov 18, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- DCF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895883 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895883 Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc. · 1989
- 1 generation backK972929 N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
- This deviceK042643 Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb…Ortho-Clinical Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| −1 | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 DCF? 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? (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 |
|---|---|---|---|
| * | K972929 | N Antiserum to Human AlbuminSummary page 3…e N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System (predicate device) which was cleared by the FDA (K972929) for IVD use. The relationship between the VITROS mALB assay and the predicate device,… | 1997 |
| * | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Summary page 4…substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K041720) for IVD use. Table 2 Table 2 lists the similarities and differences of the device characteristics between the VITROS… | 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 |
|---|---|---|---|---|
| Oct 27, 2011 | Not classified | Z-0971-2012 | Nonconforming Material/Component | Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K972929.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB). Measurement of urinary albumin aids in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin in urine (mALB).
For in vitro diagnostic use only. VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042643: Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb 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/K042643
Report an extraction error
Are you the manufacturer?
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