510(k) · Cleared

Cleared

Precision Systems Analette Chemistry Analyzer

K013654510(k) TraditionalCleared Jun 5, 2002211-day reviewClass I21 CFR 862.2170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Precision Systems, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Jun 5, 2002 as substantially equivalent to K971491 (Synermed, Inc., 1997) after a 211-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Jun 5, 2002
Review: 211 days
Class: Class I
Product code: JJF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971491 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971491 Synermed IR 200 Chemistry AnalyzerSynermed, Inc. · 1997
This deviceK013654 Precision Systems Analette Chemistry AnalyzerPrecision Systems, Inc. · 2002
Descendant · cites it directly · 0 of its ownK024182 Precision Systems Analette Chemistry Analyzer Stanbio Laboratory…Precision Systems, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K024182Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsPrecision Systems, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971491	Synermed IR 200 Chemistry Analyzer	Synermed, Inc.	1997	—
0 (this device)	K013654	Precision Systems Analette Chemistry Analyzer	Precision Systems, Inc.	2002	—
+1	K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents	Precision Systems, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K013654, 1997–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K971491	Synermed IR 200 Chemistry Analyzer 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 …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 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)…	Synermed, Inc.	1997	—

Also cleared against K971491: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents	Precision Systems, Inc.	2003	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K024182 (Precision Systems, Inc., 2003) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K971491.

How does its category compare?

All JJF devices

JJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

Too few JJF 510(k)s in any year since 2007 to give a median.

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013654: Precision Systems Analette Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013654

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026