# K042643: Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and II

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 18, 2004 after 52 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895883 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972929: N Antiserum to Human Albumin, Behring Diagnostics, Inc. (1997) Summary page 3.
- K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 4.

## Recalls of this device
- Oct 27, 2011 · Not classified · Z-0971-2012: 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 Chemist

## Indications for use
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.

Source page: https://510kreport.com/device/K042643
Methodology: https://510kreport.com/methodology