# K050328: Pregnancy-Skreen

- Pathway: 510(k) (Traditional)
- Applicant: Biochemical Diagnostic, Inc.
- Decided: Mar 29, 2005 after 48 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890577 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965171: Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426), Bio-Rad (1997) Summary page 2.
- K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis, Bio-Rad (2003) Summary page 2.
- K042446: Quantify Control and Quantify Plus Controls, Bio-Rad Laboratories, Inc. (2004) Summary page 2.

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1312-2024: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 
- Sep 14, 2015 · Class III · Z-0328-2016: CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.

## Indications for use
The Biochemical Diagnostics, Inc., Pregnancy-Skreen urine controls are intended to validate the performance of qualitative hCG methods. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.

Source page: https://510kreport.com/device/K050328
Methodology: https://510kreport.com/methodology