510(k) · Cleared
ClearedPrecision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Systems, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Mar 3, 2003 as substantially equivalent to K013654 (Precision Systems, Inc., 2002) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 3, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971491 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK971491 Synermed IR 200 Chemistry AnalyzerSynermed, Inc. · 1997
- 1 generation backK013654 Precision Systems Analette Chemistry AnalyzerPrecision Systems, Inc. · 2002
- This deviceK024182 Precision Systems Analette Chemistry Analyzer Stanbio Laboratory…Precision Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971491 | Synermed IR 200 Chemistry Analyzer | Synermed, Inc. | 1997 | — |
| −1 | K013654 | Precision Systems Analette Chemistry Analyzer | Precision Systems, Inc. | 2002 | — |
| 0 (this device) | K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents | Precision Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 CDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CDQ device
- #1 K203771 Urea Nitrogen2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K013654 | Precision Systems Analette Chemistry Analyzer | 2002 |
| * | K022072 | Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents | 2002 |
| * | K971491 | Synermed IR 200 Chemistry AnalyzerSummary page 3…900259 I1 810055 862.1110 A. Introduction: The ANALETTE m, 5 1Ok Number KO13654, is the Synermedo IR 200,5 1Ok Number K97 1491, and uses the above SynermedB reagents with each of their above 510k numbers. Medical Analysis Systems’ reagents… | 1997 |
| * | — | Hitachi 705 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CDQ devicesCDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CDQ
Too few CDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CDQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDQ
6in 2025
MAUDE reports naming product code CDQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 1 | 37 |
| 2012 | 0 | — | 0 | 44 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 231 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024182: Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024182
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026