Cleared Traditional

K931761 - QUICKVUE(TM) ONE-STEP HCG CONTROLS (POS...

K931761 is the FDA 510(k) clearance for QUICKVUE(TM) ONE-STEP HCG CONTROLS (POS... by Quidel Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K931761 · Quidel Corp. · Chemistry device
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Jun 1993
Decision
75d
Days
Class 1
Risk

K931761 is an FDA 510(k) clearance for the QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI). Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K931761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date June 22, 1993
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 268
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K931761.
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CANNABINOID URINE CONTROLS
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SUGAR CHEX LINEARITY FOR THE ONE TOUCH
K925479 · Streck Laboratories, Inc. · Jan 1993
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089 · Bio-Rad · Apr 1992