Cleared Traditional

K981838 - ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002

K981838 is an FDA 510(k) clearance for ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002, manufactured by Unotech Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K981838 · Unotech Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
30d
Days
Class 2
Risk

K981838 is an FDA 510(k) clearance for the ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Unotech Diagnostics, Inc. (San Leandro, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 30 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 Unotech Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981838

510(k) Number K981838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date June 25, 1998
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K981838.
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
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MINISTRIP/ SERUM AND URINE COMBO HCG TEST
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QUICKCARD PRO HCG TEST, MODEL 9008
K980896 · Phamatech · Apr 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998