Cleared Traditional

QUANTUMATIC DUAL-WAVELENGTH SPECTRO (K812865) - FDA 510(k) Clearance

Class I Chemistry device.

K812865 · Abbott Laboratories · Chemistry device
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Nov 1981
Decision
28d
Days
Class 1
Risk

K812865 is an FDA 510(k) clearance for the QUANTUMATIC DUAL-WAVELENGTH SPECTRO. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 10, 1981 after a review of 28 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 Abbott Laboratories devices

Submission Details

510(k) Number K812865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1981
Decision Date November 10, 1981
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 53
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K812865.
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · Helena Laboratories · Aug 1982
PHADEZYM ANALYZER
K813563 · Pharmacia, Inc. · Mar 1982
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · Beckman Instruments, Inc. · Mar 1981
DRUG DETECTION SYSTEM
K802619 · Syva Co. · Oct 1980
AGA UV PHOTOMETER
K801499 · Syva Co. · Aug 1980