# K022072: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Precision Systems, Inc.
- Decided: Aug 23, 2002 after 58 days
- Product code: CIX (Bromcresol Green Dye-Binding, 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Precision Systems Inc, ANACETTE using Synermed reagents: named in the summary without a submission number

## Most influential descendants
- K024182: Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents (2003), 0 descendants of its own

## Indications for use
The Precision SystemsTMANALETTETM Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL,), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lipase, 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 Synemecis® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets

Source page: https://510kreport.com/device/K022072
Methodology: https://510kreport.com/methodology