Cleared Traditional

K981770 - RAPIDHCG PREGNANCY TEST

K981770 is an FDA 510(k) clearance for RAPIDHCG PREGNANCY TEST, manufactured by Rapid Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K981770 · Rapid Diagnostics, Inc. · Chemistry device
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Jun 1998
Decision
17d
Days
Class 2
Risk

K981770 is an FDA 510(k) clearance for the RAPIDHCG PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Rapid Diagnostics, Inc. (Burlingame, US). The FDA issued a Cleared decision on June 5, 1998 after a review of 17 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 Rapid Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981770

510(k) Number K981770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1998
Decision Date June 05, 1998
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K981770.
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444 · Princeton BioMeditech Corp. · Jul 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · Princeton BioMeditech Corp. · Jun 1998
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
K981838 · Unotech Diagnostics, Inc. · Jun 1998
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
K981512 · Skd, Inc. A Beckman Coulter Co. · May 1998
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
K980736 · Acon Laboratories Co. · Apr 1998
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
K981165 · Germaine Laboratories, Inc. · Apr 1998