# K961965: Sure Check Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Chembio Diagnostic Systems, Inc.
- Decided: Jun 24, 1996 after 35 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923925 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923925: HCG Stat-Pak, Chembio Diagnostic Systems, Inc. (1992) Summary page 1.
- (no number) Clearblue Easy Pregnancy Test: named in the summary without a submission number
- (no number) E.P.T. Pregnancy Test: named in the summary without a submission number

## Recalls of this device
- Oct 6, 2004 · Not classified · Z-0276-05: Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functiona

## Indications for use
An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.

Source page: https://510kreport.com/device/K961965
Methodology: https://510kreport.com/methodology