Cleared Traditional

K961792 - BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS

K961792 is an FDA 510(k) clearance for BIOCIRCUITS IOS SERUM PREGNANCY TEST CA..., manufactured by Biocircuits Corp.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K961792 · Biocircuits Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
104d
Days
Class 2
Risk

K961792 is an FDA 510(k) clearance for the BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on August 21, 1996 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocircuits Corp. devices

FDA 510(k) Submission Details - K961792

510(k) Number K961792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1996
Decision Date August 21, 1996
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DHA System, Test, Human Chorionic Gonadotropin

All 54
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K961792.
MIDSTREAM HOME REGNANCY TEST
K973825 · Germaine Laboratories, Inc. · Dec 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
K970894 · Johnson & Johnson Clinical Diagnostics, Inc. · Apr 1997
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · Dade Chemistry Systems, Inc. · Mar 1997
ELECSYS HCG ASSAY
K961487 · Boehringer Mannheim Corp. · Jun 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
K961351 · Bayer Corp. · Jun 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
K955707 · Excel Scientific, Inc. · May 1996