# K133002: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Apr 16, 2015 after 569 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- 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
Longest line of descent: 2 generations back to K022232 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983424: Abbott Archeitect Total B-HCG, Abbott Laboratories (1998) Summary page 5.
- K121237: Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls LE, Cliniqa Corporation (2012) Summary page 5.

## Indications for use
The i-STAT® Total Beta-Human Chorionic Gonadotropin (β-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of β-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only. The i-STAT® Total β-hCG Controls are used to monitor performance of the i-STAT Total β-hCG test. The i-STAT® Total β-hCG Calibration Verification Materials are used to verify the calibration of the i-STAT Total β-hCG test throughout the reportable range.

Source page: https://510kreport.com/device/K133002
Methodology: https://510kreport.com/methodology