510(k) · Cleared
ClearedThe Quantech Fastraq Automated Analyzer, and the Quantech Prepaq Total HCG Test Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantech, Ltd. · NAL Test, Immunoassay, Biosensor, Hcg
Cleared on Jan 18, 2002 after a 140-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 18, 2002
- Review
- 140 days
- Class
- Class II
- Product code
- NAL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 NAL? 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? (3)
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 |
|---|---|---|---|
| * | — | AVDIA Centaur Named without a submission number | |
| * | — | Abbott AxSym Named without a submission number | |
| * | — | Dade Behring RxL 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.
How does its category compare?
All NAL devicesNAL Test, Immunoassay, Biosensor, Hcg: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAL
FDA has decided no NAL device since 2007.
Median 510(k) review, days · NAL
Too few NAL 510(k)s in any year since 2007 to give a median.
Recalls per year · NAL
No recall names NAL since 2007.
Adverse event reports per year · NAL
12in 2016
MAUDE reports naming product code NAL, 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 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantech PrePaQ Total hCG Test Cartridge is intended for use with the FasTraQ Automated Analyzer to provide rapid, quantitative measurement of human chorionic gonadotropin (hCG) in whole blood for the determination of pregnancy. The Analyzer and hCG Cartridge combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. The FasTraQ System is designed for use by non-laboratory medical professionals in emergency departments, STAT or central laboratories.
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/K012943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012943: The Quantech Fastraq Automated Analyzer, and the Quantech Prepaq Total HCG Test Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012943
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026