510(k) · Cleared
ClearedLiquid GGT (Gamma Glutamyl Transferase) Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
Cleared on Oct 10, 1997 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 10, 1997
- Review
- 49 days
- Class
- Class I
- Product code
- JQB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JQB? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 JQB devicesJQB Kinetic Method, Gamma-Glutamyl Transpeptidase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JQB
FDA has decided no JQB device since 2007.
Median 510(k) review, days · JQB
Too few JQB 510(k)s in any year since 2007 to give a median.
Recalls per year · JQB
No recall names JQB since 2007.
Adverse event reports per year · JQB
2in 2024
MAUDE reports naming product code JQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 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 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative kinetic determination of gamma glutamy! transferase in serum. lt is intended for in vitro diagnostic use only. The determination of gamma glutamyl transferase in serum is most commonly performed for the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and secondary liver tumors.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973157 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973157: Liquid GGT (Gamma Glutamyl Transferase) Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973157
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)
- Page last updated Nov 3, 2026