Cleared Traditional

AUTOREADER CALIBRATION TEST PLATE (K900579) - FDA 510(k) Clearance

Class I Chemistry device.

K900579 · Bio-Tek Instruments, Inc. · Chemistry device
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Feb 1990
Decision
20d
Days
Class 1
Risk

K900579 is an FDA 510(k) clearance for the AUTOREADER CALIBRATION TEST PLATE. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on February 27, 1990 after a review of 20 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K900579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date February 27, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 K900579.
BEHRING CHROMOTIMER
K901829 · Behring Diagnostics, Inc. · Jul 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1990
NOVAPATH MICROPLATE READER
K900776 · Bio-Rad · Apr 1990
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