Cleared Traditional

K882086 - QTEST(TM) PREGNANCY

K882086 is the FDA 510(k) clearance for QTEST(TM) PREGNANCY by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K882086 · Quidel Corp. · Chemistry device
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Jul 1988
Decision
71d
Days
Class 2
Risk

K882086 is an FDA 510(k) clearance for the QTEST(TM) PREGNANCY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 71 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 Quidel Corp. devices

Submission Details

510(k) Number K882086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1988
Decision Date July 28, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K882086.
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · Ciba Corning Diagnostics Corp. · Oct 1988
CLEARVIEW HCG
K883777 · Unipath , Ltd. · Oct 1988
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · Amersham Corp. · Jun 1988
QUIDEL PREGNANCY TEST
K881595 · Quidel Corp. · May 1988
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988