Cleared Traditional

K890615 - DIRECTIGEN1-2-3 BHCG PREGNANCY TEST

K890615 is an FDA 510(k) clearance for DIRECTIGEN1-2-3 BHCG PREGNANCY TEST, manufactured by Quidel Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K890615 · Quidel Corp. · Chemistry device
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Apr 1989
Decision
70d
Days
Class 2
Risk

K890615 is an FDA 510(k) clearance for the DIRECTIGEN1-2-3 BHCG PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on April 18, 1989 after a review of 70 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

FDA 510(k) Submission Details - K890615

510(k) Number K890615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1989
Decision Date April 18, 1989
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 251
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K890615.
IMX TOTAL B-HCG
K894182 · Abbott Laboratories · Sep 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · Abbott Laboratories · Sep 1989
HCG IRMA II
K891770 · Pacific Biotech, Inc. · May 1989
VENTREX COATED TUBE HCG
K890549 · Ventrex Laboratories, Inc. · Mar 1989
TARGET(TM) QUANTITATIVE HCG
K890131 · V-Tech, Inc. · Mar 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
K884616 · Pacific Biotech, Inc. · Jan 1989