510(k) · Cleared
ClearedClinitek Atlas Pro 12 Reagent Pak System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · JFY Enzymatic Method, Creatinine
Cleared on Jul 5, 2002 after a 63-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 5, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JFY? 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 JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | — | Multistix PROTM11 Reagent Strips Named without a submission number | |
| * | — | Multistix PROTMlOLS Reagent Strips Named without a submission number | |
| * | — | Multistix PROTM7G Reagent Strips Named without a submission number | |
| * | — | Clinitekb 50 Named without a submission number | |
| * | — | Clinitekb 100 Named without a submission number | |
| * | — | Clinitekb 200+ Named without a submission number | |
| * | — | CLINITEKB 500 Urine Chemistry Analyzers 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.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLASB Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/& albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A…
Read the full statement (176 words)
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLASB Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/& albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive lZfh pad that is used for the determination of the specimen color.
The CLlNlTEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic infomiation to rule out certain disease states. The CLINITEK ATLAS PRO Reagent I’ak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021428: Clinitek Atlas Pro 12 Reagent Pak System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026