510(k) · Cleared
ClearedClinitek Microalbumin Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CJG Tetrabromo-M-Cresolsulfonphthalein, Albumin
Cleared on Sep 9, 1997 after a 50-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Sep 9, 1997
- Review
- 50 days
- Class
- Class II
- Product code
- CJG
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK972706 Clinitek Microalbumin Reagent StripsBayer Corp. · 1997
- Descendant · cites it directly · 16 of its ownK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- Descendant · 2 generations on · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · cites it directly · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK070929 Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003 · cites it directly16descendants
- K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · 2 generations on6descendants
- K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · cites it directly3descendants
- K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007 · 2 generations on3descendants
- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972706 | Clinitek Microalbumin Reagent Strips | Bayer Corp. | 1997 | — |
| +1 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| +2 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| +1 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| +2 | K070929 | Acon U120 Urine Analyzer, Model U111-101 | ACON Laboratories, Inc. | 2007 | — |
| +3 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 CJG? 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
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | — | Micral-Test® strips (Boehringer Mannheim Corporation) Named without a submission number | |
| * | — | Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.) Named without a submission number | |
| * | — | SPQII™ Reagent (INCSTAR Corp.)/Roche COBAS-FARA® II Analyzer/Ciba-Corning Express Plus Named without a submission number | |
| * | — | Microprotein Reagent (Sigma Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical… Named without a submission number | |
| * | — | Quantimetrics BGR Total Protein (Quantimetrics) TECHNICON RA® 1000 Random Access Analyzer Named without a submission number | |
| * | — | CX3 Creatinine Reagent (Beckman)/Beckman CX3 SYNCHRON® Analyzer Named without a submission number | |
| * | — | Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax Analytical System Named without a submission number | |
| * | — | Miles Creatinine Reagent (Bayer) TECHNICON RA 1000 Random Access Analyzer Named without a submission number | |
| * | — | Dade® Creatinine Reagent/DuPont XL System Named without a submission number | |
| * | — | DCA 2000+ Microalbumin/Creatinine Assay (Bayer) Named without a submission number |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031947 (Bayer Healthcare, LLC, 2003) has gone furthest, with 16 descendants of its own.
How does its category compare?
All CJG devicesCJG Tetrabromo-M-Cresolsulfonphthalein, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJG
FDA has decided no CJG device since 2007.
Median 510(k) review, days · CJG
Too few CJG 510(k)s in any year since 2007 to give a median.
Recalls per year · CJG
No recall names CJG since 2007.
Adverse event reports per year · CJG
No MAUDE report names CJG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria)@ in urine, and also determine the albumin-to-creati inie ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
CLINITEK Microalbumin Reagent Strips are for professional use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972706: Clinitek Microalbumin Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972706
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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