# K024182: Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Precision Systems, Inc.
- Decided: Mar 3, 2003 after 74 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971491 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013654: Precision Systems Analette Chemistry Analyzer, Precision Systems, Inc. (2002)
- K022072: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents, Precision Systems, Inc. (2002)
- K971491: Synermed IR 200 Chemistry Analyzer, Synermed, Inc. (1997) Summary page 3.
- (no number) Hitachi 705: named in the summary without a submission number

## Indications for use
The Precision SystemsTM ANALETTEm Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includesHDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an “open” System, which can use a variety of commercially manufactured reagents such as but not limited to SynermedsQ Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging

Source page: https://510kreport.com/device/K024182
Methodology: https://510kreport.com/methodology