Cleared Traditional

K990576 - OSOM CARD PREGNANCY TEST, MODEL 103

K990576 is an FDA 510(k) clearance for OSOM CARD PREGNANCY TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K990576 · Wyntek Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
14d
Days
Class 2
Risk

K990576 is an FDA 510(k) clearance for the OSOM CARD PREGNANCY TEST, MODEL 103. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 9, 1999 after a review of 14 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 Wyntek Diagnostics, Inc. devices

FDA 510(k) Submission Details - K990576

510(k) Number K990576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date March 09, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K990576.
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · Phamatech · Nov 1999
SAS HCG-CHECK
K991193 · Sa Scientific, Inc. · May 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · Unipath , Ltd. · Apr 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · Abbott Laboratories · Feb 1999
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
K984075 · Alfa Scientific Designs, Inc. · Feb 1999
ACON MIDSTREAM PREGNANCY TEST
K983090 · ACON Laboratories, Inc. · Nov 1998