Cleared Traditional

BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER (K853453) - FDA 510(k) Clearance

Class I Chemistry device.

K853453 · Bio Automed Systems, Inc. · Chemistry device
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Sep 1985
Decision
45d
Days
Class 1
Risk

K853453 is an FDA 510(k) clearance for the BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Bio Automed Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 30, 1985 after a review of 45 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 Automed Systems, Inc. devices

Submission Details

510(k) Number K853453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date September 30, 1985
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 35
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K853453.
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
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · Em Diagnostic Systems, Inc. · Aug 1985
UROTRON RL9
K850348 · Boehringer Mannheim Corp. · Mar 1985
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982