# K963142: Dca 2000 + Microalbumin/Creatinine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 27, 1996 after 45 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Incstar® Antibody Reagent Set for Microalbumin SPQ™ Test System: named in the summary without a submission number
- (no number) Diagnostic Products Corporation Double Antibody Albumin RIA for microalbuminuria: named in the summary without a submission number
- (no number) Pharmacia Albumin RIA: named in the summary without a submission number
- (no number) Behring Turbitimer semiautomated method for albumin: named in the summary without a submission number
- (no number) Beckman Array® nephelometric method for albumin: named in the summary without a submission number
- (no number) Roche® Reagent for CREATININE [Roche Cobas™-Mira]: named in the summary without a submission number
- (no number) automated Jaffe methods for Hitachi, Olympus and Dupont Dimension analyzers: named in the summary without a submission number
- (no number) Sigma manual alkaline picrate method: named in the summary without a submission number

## Most influential descendants
- K071466: Dca Vantage, Model 5075 (2007), 8 descendants of its own
- K072409: Afinion Acr and Acr Control (2008), 5 descendants of its own
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer (2017), 2 descendants of its own
- K082275: Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023 (2010), 2 descendants of its own
- K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer (2024), 1 descendant of its own

## Indications for use
The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

Source page: https://510kreport.com/device/K963142
Methodology: https://510kreport.com/methodology