Cleared Traditional

K945331 - AURAFLEX HCG

K945331 is an FDA 510(k) clearance for AURAFLEX HCG, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K945331 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
139d
Days
Class 2
Risk

K945331 is an FDA 510(k) clearance for the AURAFLEX HCG. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on March 20, 1995 after a review of 139 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K945331

510(k) Number K945331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date March 20, 1995
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
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 45
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K945331.
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
AMERLITE HCG-60 ASSAY
K952283 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · Princeton BioMeditech Corp. · Mar 1995
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · Baxter Diagnostics, Inc. · Oct 1992