510(k) · Cleared
ClearedClinitek Advantus, Model 1420
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Dec 28, 2006 as substantially equivalent to K926359 (Heraeus Kulzer, Inc., 1993) after a 59-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 28, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926359 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926359 Clinitek 200+ Urine Chemistry AnalyzerHeraeus Kulzer, Inc. · 1993
- This deviceK063276 Clinitek Advantus, Model 1420Bayer Healthcare, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926359 | Clinitek 200+ Urine Chemistry Analyzer | Heraeus Kulzer, Inc. | 1993 | — |
| 0 (this device) | K063276 | Clinitek Advantus, Model 1420 | Bayer Healthcare, LLC | 2006 | — |
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 JIL? 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 JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K926359 | Clinitek 200+ Urine Chemistry AnalyzerSummary page 1…K 200+ Common name Urine Chemistry Analyzer Urine Chemistry Analyzer 510(k) Number CLINITEK family internal filing K926359 Manufacturer Bayer HealthCare, LLC Heraeus Kulzer, Inc. Device Description The CLINITEK Advant… | 1993 |
| * | — | Clinitek 500 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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K926359.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CLINITEK AdvantusTM Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to…
Read the full statement (96 words)
The CLINITEK AdvantusTM Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips.
This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to assist diagnosis in the following areas:
* Kidney Function
* Urinary tract infections
* Metabolic disorders (e.g. diabetes mellitus)
* Liver Function
Tests performed using the CLINITEK AdvantusTM are intended for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063276: Clinitek Advantus, Model 1420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063276
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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