# K012943: The Quantech Fastraq Automated Analyzer, and the Quantech Prepaq Total HCG Test Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Quantech, Ltd.
- Decided: Jan 18, 2002 after 140 days
- Product code: NAL (Test, Immunoassay, Biosensor, Hcg)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AVDIA Centaur: named in the summary without a submission number
- (no number) Abbott AxSym: named in the summary without a submission number
- (no number) Dade Behring RxL: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K012943
Methodology: https://510kreport.com/methodology