Cleared Traditional

K844281 - PTK HEALTHCHECK PREGNANCY TEST KIT

K844281 is the FDA 510(k) clearance for PTK HEALTHCHECK PREGNANCY TEST KIT by Healthcheck Corp.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K844281 · Healthcheck Corp. · Chemistry device
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Dec 1984
Decision
35d
Days
Class 2
Risk

K844281 is an FDA 510(k) clearance for the PTK HEALTHCHECK PREGNANCY TEST KIT. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Healthcheck Corp. (Cheshire, US). The FDA issued a Cleared decision on December 10, 1984 after a review of 35 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 Healthcheck Corp. devices

Submission Details

510(k) Number K844281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1984
Decision Date December 10, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K844281.
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