# K021428: Clinitek Atlas Pro 12 Reagent Pak System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 5, 2002 after 63 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Multistix PROTM11 Reagent Strips: named in the summary without a submission number
- (no number) Multistix PROTMlOLS Reagent Strips: named in the summary without a submission number
- (no number) Multistix PROTM7G Reagent Strips: named in the summary without a submission number
- (no number) Clinitekb 50: named in the summary without a submission number
- (no number) Clinitekb 100: named in the summary without a submission number
- (no number) Clinitekb 200+: named in the summary without a submission number
- (no number) CLINITEKB 500 Urine Chemistry Analyzers: named in the summary without a submission number

## Indications for use
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLASB Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/& albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive lZfh pad that is used for the determination of the specimen color. The CLlNlTEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic infomiation to rule out certain disease states. The CLINITEK ATLAS PRO Reagent I’ak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.

Source page: https://510kreport.com/device/K021428
Methodology: https://510kreport.com/methodology