Cleared Traditional

K834474 - H.P.T. HOME PREG. TEST KIT & A.P.T.

K834474 is the FDA 510(k) clearance for H.P.T. HOME PREG. TEST KIT & A.P.T. by Biomedical Research & Development Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K834474 · Biomedical Research & Development Laboratories, Inc. · Chemistry device
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Sep 1984
Decision
283d
Days
Class 2
Risk

K834474 is an FDA 510(k) clearance for the H.P.T. HOME PREG. TEST KIT & A.P.T.. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Biomedical Research & Development Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 283 days - an extended review 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: 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 Biomedical Research & Development Laboratories, Inc. devices

Submission Details

510(k) Number K834474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date September 28, 1984
Days to Decision 283 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 88d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 116
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K834474.
CLEARBLUE PREGNANCY TESTING KIT
K861168 · Unipath , Ltd. · Apr 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986
ANSWER
K852274 · Armkel, LLC · Jun 1985
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984
BETA STICK, PREGNANCY TEST
K841415 · Quidel Corp. · Jul 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · Organon, Inc. · May 1984