Cleared Traditional

K873583 - AUTO-EIA

K873583 is an FDA 510(k) clearance for AUTO-EIA, manufactured by Labsystems, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K873583 · Labsystems, Inc. · Chemistry device
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Sep 1987
Decision
19d
Days
Class 1
Risk

K873583 is an FDA 510(k) clearance for the AUTO-EIA. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Labsystems, Inc. (Morton Grove, US). The FDA issued a Cleared decision on September 22, 1987 after a review of 19 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.

FDA 510(k) Submission Details - K873583

510(k) Number K873583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1987
Decision Date September 22, 1987
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 K873583.
DYNATECH MR 300 MANUAL MICROELISA
K874244 · Dynatech Laboratories, Inc. · Nov 1987
MICRO-CHEM ANALYZER
K873638 · Ocean Scientific, Inc. · Sep 1987
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K873678 · Slt Labinstruments, Inc. · Sep 1987
SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000
K872749 · Secomam Co. · Sep 1987
MICRO-READER II
K873138 · Hyperion, Inc. · Sep 1987
MODEL 690 SPECTROPHOTOMETER
K873408 · Abbott Diagnostics · Sep 1987
K873583 · AUTO-EIA
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