# K013654: Precision Systems Analette Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Precision Systems, Inc.
- Decided: Jun 5, 2002 after 211 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971491 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971491: Synermed IR 200 Chemistry Analyzer, Synermed, Inc. (1997). Our reading of the summary gave “K971491” beside “510(k)”; FDA’s K971491 is the only number that fits it and carries the summary’s name for the device. Summary page 4.

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

## Indications for use
The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, 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 Synermed’s Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, C02, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Magnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, lron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed’s name IR 200

Source page: https://510kreport.com/device/K013654
Methodology: https://510kreport.com/methodology