Cleared Traditional

K893738 - QUIDEL REFLECTANCE ANALYZER

K893738 is the FDA 510(k) clearance for QUIDEL REFLECTANCE ANALYZER by Quidel Corp.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K893738 · Quidel Corp. · Chemistry device
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Aug 1989
Decision
86d
Days
Class 1
Risk

K893738 is an FDA 510(k) clearance for the QUIDEL REFLECTANCE ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 K893738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date August 11, 1989
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 72
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K893738.
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COBAS READY
K896007 · Roche Diagnostic Systems, Inc. · Dec 1989
MICROTRAK EIA AUTOREADER
K891270 · Syva Co. · Jun 1989
BEHRING TURBITIMER
K883646 · Behring Diagnostics, Inc. · Oct 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988