510(k) · Cleared
ClearedQuantify (901)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hematronix, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Aug 15, 1997 as substantially equivalent to K890577 (Kenlor Industries, Inc., 1989) after a 25-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 15, 1997
- Review
- 25 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890577 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- This deviceK972710 Quantify (901)Hematronix, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| 0 (this device) | K972710 | Quantify (901) | Hematronix, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K890577 | Kenlor Liquid Urine ControlSummary page 1…linical Chemistry Urine Control Classification Name Quality Control Material per 21CFR862.1660 Substantially Equivalent Device: Kenlor Liquid Urine Control see 510(k) #K890577 Please note: qUAntify is currently “manufactured for" HEMATRONIX, INC. by Kenlor Industries. It is our intention to manufacture… | 1989 |
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.
- 1 other device also cites its predicate K890577.
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?
The Hematronix qUAntify TM Control System is a liquid, ready-to-use urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick…
Read the full statement (108 words)
The Hematronix qUAntify TM Control System is a liquid, ready-to-use urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
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/K972710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972710: Quantify (901).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972710
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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