# K972706: Clinitek Microalbumin Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 9, 1997 after 50 days
- Product code: CJG (Tetrabromo-M-Cresolsulfonphthalein, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 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) Micral-Test® strips (Boehringer Mannheim Corporation): named in the summary without a submission number
- (no number) Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.): named in the summary without a submission number
- (no number) SPQII™ Reagent (INCSTAR Corp.)/Roche COBAS-FARA® II Analyzer/Ciba-Corning Express Plus: named in the summary without a submission number
- (no number) Microprotein Reagent (Sigma Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical System/DuPont XL System: named in the summary without a submission number
- (no number) Quantimetrics BGR Total Protein (Quantimetrics) TECHNICON RA® 1000 Random Access Analyzer: named in the summary without a submission number
- (no number) CX3 Creatinine Reagent (Beckman)/Beckman CX3 SYNCHRON® Analyzer: named in the summary without a submission number
- (no number) Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax Analytical System: named in the summary without a submission number
- (no number) Miles Creatinine Reagent (Bayer) TECHNICON RA 1000 Random Access Analyzer: named in the summary without a submission number
- (no number) Dade® Creatinine Reagent/DuPont XL System: named in the summary without a submission number
- (no number) DCA 2000+ Microalbumin/Creatinine Assay (Bayer): named in the summary without a submission number

## Most influential descendants
- K031947: Bayer Clinitek Status Analyzer (2003), 16 descendants of its own
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), 3 descendants of its own
- K070929: Acon U120 Urine Analyzer, Model U111-101 (2007), 3 descendants of its own
- K141874: Uriscan Optima (2015), 2 descendants of its own

## Indications for use
CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria)@ in urine, and also determine the albumin-to-creati inie ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.

Source page: https://510kreport.com/device/K972706
Methodology: https://510kreport.com/methodology