Cleared Traditional

K990578 - OSOM CARD II HCG-URINE TEST, MODEL 102

K990578 is an FDA 510(k) clearance for OSOM CARD II HCG-URINE TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K990578 · 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

K990578 is an FDA 510(k) clearance for the OSOM CARD II HCG-URINE TEST, MODEL 102. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), 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 - K990578

510(k) Number K990578 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.

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 252
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K990578.
MODIFICATION OF SAS SERUM/URINE HCG
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K991095 · Phamatech · Apr 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · Alfa Scientific Designs, Inc. · Feb 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077 · Alfa Scientific Designs, Inc. · Feb 1999
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
K984079 · Alfa Scientific Designs, Inc. · Feb 1999