510(k) · Cleared
ClearedPrecision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Systems, Inc. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Aug 23, 2002 after a 58-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 23, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK022072 Precision Systems Analette Chemistry Analyzer & Medical Analysis…Precision 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 |
|---|---|---|---|---|---|
| 0 (this device) | K022072 | Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems… | 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 |
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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | — | Precision Systems Inc, ANACETTE using Synermed reagents Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents | 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?
- Of its descendants, K024182 (Precision Systems, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (121 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022072: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022072
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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