510(k) · Cleared
ClearedDRX QT. HCG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metrika, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Sep 17, 1999 as substantially equivalent to K850570 (American Dade, 1985) and 1 other predicate after a 137-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Sep 17, 1999
- Review
- 137 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850570 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK850570 Stratus HCG Fluorometric Enzyme ImmunoassayAmerican Dade · 1985
- This deviceK991532 DRX QT. HCGMetrika, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850570 | Stratus HCG Fluorometric Enzyme Immunoassay | American Dade | 1985 | — |
| 0 (this device) | K991532 | DRX QT. HCG | Metrika, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K850570 | Stratus HCG Fluorometric Enzyme ImmunoassaySummary page 4…nological Similarities and Differences to the Predicate (continued) Differences Between DRx® Qt. hCG and Stratus® phCG "CHARACTERISTIC DRx® Qt. hCG 18 Stratus® BhCG K850570 Methodology/Testing (straight addition of whole blood specimen into device for testing) DRx® Qt. hCG is a four channel, | Stra… | 1985 |
| * | K860906 | Stratus Immunoassay Controls, Levels I, II, IiiSummary page 5…t. hCG Control Set and Dade® Immunoassay Controls Comprehensive Tri-Level ARACTERISTIC DRx" Qt. hCG Control Set Dade® Immunoassay i detmlsfiompxehénsive " "Tri-Level K860906 Analyte(s) hCG (Various constituents), e.g. Acetaminophen Lidocaine Digoxin TSH Vitamin B12 hGH FSH PSA hCG hLH, etc. Matrix… | 1986 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DRx® Qt. hCG is a rapid, single-use, point-of-care device for the quantitative measurement of human chorionic gonadotropin (total BhCG) in capillary and venous whole blood samples. The device is for professional use as an aid in the assessment of pregnancy status.
The DRx® Qt. hCG Control Set is a two level, assayed, liquid control containing human chorionic gonadotropin for the evaluation of precision and accuracy of the DRx® Qt. hCG device.
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/K991532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991532: DRX QT. HCG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991532
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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