Cleared Traditional

K901695 - QUICK CHEM II

K901695 is an FDA 510(k) clearance for QUICK CHEM II, manufactured by Seradyn, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K901695 · Seradyn, Inc. · Chemistry device
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May 1990
Decision
44d
Days
Class 1
Risk

K901695 is an FDA 510(k) clearance for the QUICK CHEM II. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 44 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.

FDA 510(k) Submission Details - K901695

510(k) Number K901695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date May 24, 1990
Days to Decision 44 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
45d faster than avg
Panel avg: 89d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 256
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K901695.
EURAMARK 610 PHOTOMETER
K903164 · Euro-American Marketing Group, Inc. · Aug 1990
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K902776 · Slt Labinstruments, Inc. · Jul 1990
BEHRING CHROMOTIMER
K901829 · Behring Diagnostics, Inc. · Jul 1990
MPR-4A - MICRO-PLATE READER
K901965 · Tosoh Corp. · May 1990
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
K901542 · Source Scientific Systems, Inc. · Apr 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1990
K901695 · QUICK CHEM II
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