Cleared Traditional

K913122 - DIRECTIGEN 1-2-3(TM) HCG TEST

K913122 is the FDA 510(k) clearance for DIRECTIGEN 1-2-3(TM) HCG TEST by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K913122 · Quidel Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1991
Decision
32d
Days
Class 2
Risk

K913122 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3(TM) HCG 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 August 16, 1991 after a review of 32 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 K913122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1991
Decision Date August 16, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K913122.
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · Eastman Kodak Company · Mar 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · Eastman Kodak Company · Jan 1992
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · Unipath , Ltd. · Oct 1991
IMX HCG
K912534 · Abbott Laboratories · Jul 1991
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
CLEARVIEW HCG SERUM/URINE
K905741 · Unipath , Ltd. · May 1991