Cleared Traditional

MICROTRAK EIA AUTOREADER (K891270) - FDA 510(k) Clearance

Class I Chemistry device.

K891270 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
99d
Days
Class 1
Risk

K891270 is an FDA 510(k) clearance for the MICROTRAK EIA AUTOREADER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K891270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1989
Decision Date June 16, 1989
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
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 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K891270.
MICROTAK PLUS
K913840 · Syva Co. · Sep 1991
IMX SELECT ANALYZER
K912368 · Abbott Laboratories · Sep 1991
MICROTRAK MANAGER
K912959 · Syva Co. · Jul 1991
SYVA Q-SPEC PHOTOMETER
K871307 · Syva Co. · May 1987
ADX(TM) ANALYZER
K864566 · Abbott Laboratories · Feb 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986