Cleared Traditional

K961351 - HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

K961351 is an FDA 510(k) clearance for HCG ER METHOD FOR THE TECHNICON IMMUNO ..., manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K961351 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
59d
Days
Class 2
Risk

K961351 is an FDA 510(k) clearance for the HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL .... Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 3, 1996 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Corp. devices

FDA 510(k) Submission Details - K961351

510(k) Number K961351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date June 03, 1996
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 K961351.
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · Dade Chemistry Systems, Inc. · Mar 1997
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
K961792 · Biocircuits Corp. · Aug 1996
ELECSYS HCG ASSAY
K961487 · Boehringer Mannheim Corp. · Jun 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
K955707 · Excel Scientific, Inc. · May 1996
AMERLITE HCG-60 ASSAY
K952283 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
AURAFLEX HCG
K945331 · Organon Teknika Corp. · Mar 1995