Cleared Traditional

K954065 - BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

K954065 is an FDA 510(k) clearance for BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT, manufactured by Biochem Immunosystems (U.S.), Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K954065 · Biochem Immunosystems (U.S.), Inc. · Chemistry device
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Jul 1996
Decision
315d
Days
Class 2
Risk

K954065 is an FDA 510(k) clearance for the BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biochem Immunosystems (U.S.), Inc. (Allentown, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biochem Immunosystems (U.S.), Inc. devices

FDA 510(k) Submission Details - K954065

510(k) Number K954065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1995
Decision Date July 10, 1996
Days to Decision 315 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 88d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K954065.
PS-UNIT CASSETTE/SERUM HCG
K963133 · International Newtech Development, Inc. · Nov 1996
VISUALINE D HCG
K963408 · Sun Biomedical Laboratories, Inc. · Oct 1996
SCRIPPS LABORATORIES HCG ONE-STEP
K962906 · Scripps Laboratories, Inc. · Aug 1996
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996
DSL ACTIVE I-HCG IRMA
K960357 · Diagnostic Systems Laboratories, Inc. · May 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · Bionike Laboratories, Inc. · Apr 1996