510(k) · Cleared
ClearedUrine Chemistry Control, Level 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Technologies, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Sep 3, 1999 as substantially equivalent to K880495 (Bio-Rad, 1988) after a 32-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Sep 3, 1999
- Review
- 32 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880495 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880495 Lyphochek Quantitative Urine Control Abnormal (2)Bio-Rad · 1988
- This deviceK992578 Urine Chemistry Control, Level 2Consolidated Technologies, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880495 | Lyphochek Quantitative Urine Control Abnormal (2) | Bio-Rad | 1988 | — |
| 0 (this device) | K992578 | Urine Chemistry Control, Level 2 | Consolidated Technologies, Inc. | 1999 | — |
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 JJW? 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? (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 |
|---|---|---|---|
| * | K880495 | Lyphochek Quantitative Urine Control Abnormal (2)Summary page 1…ass | , Product code: JJW 21 CFR 862:1660 : Urinalysis Controls (Assayed and Unassayed) Predicate device: LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880495 Device description: Urine Chemistry Control, Leve! 2, is designed to monitor the performance of urine chemistry test procedures… | 1988 |
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.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Urine Chemistry Control, Level 2, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
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/K992578 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992578: Urine Chemistry Control, Level 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992578
Report an extraction error
Are you the manufacturer?
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