Cleared Traditional

PICOLITE (K822800) - FDA 510(k) Clearance

Class I Chemistry device.

K822800 · United Technologies Packard · Chemistry device
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Oct 1982
Decision
40d
Days
Class 1
Risk

K822800 is an FDA 510(k) clearance for the PICOLITE. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by United Technologies Packard (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 40 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 United Technologies Packard devices

Submission Details

510(k) Number K822800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1982
Decision Date October 27, 1982
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 45
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K822800.
BEHRING VECTOR PHOTOMETER
K851098 · Behring Diagnostics, Inc. · Apr 1985
UROTRON RL9
K850348 · Boehringer Mannheim Corp. · Mar 1985
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · Helena Laboratories · Aug 1982
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · Abbott Laboratories · Nov 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · Beckman Instruments, Inc. · Mar 1981