Cleared Traditional

K881877 - COBAS EIA(TM) PHOTOMETER

K881877 is an FDA 510(k) clearance for COBAS EIA(TM) PHOTOMETER, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K881877 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
37d
Days
Class 1
Risk

K881877 is an FDA 510(k) clearance for the COBAS EIA(TM) PHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 37 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 - K881877

510(k) Number K881877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1988
Decision Date June 10, 1988
Days to Decision 37 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
52d faster than avg
Panel avg: 89d · This submission: 37d
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 245
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K881877.
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · Behring Diagnostics, Inc. · Aug 1988
ASTROSCAN 2100 MICROTITER PLATE READER
K881458 · Astroscan , Ltd. · Jun 1988
EASY WASHER II MICROPLATE WASHER
K881797 · Slt Labinstruments, Inc. · Jun 1988
UVMAX KINETIC MICROPLATE READER
K881803 · Molecular Devices Corp. · May 1988
LUMICON
K873893 · Hamilton Co. · Jan 1988
LAD MODEL 735 LUMINOMETER
K874262 · Los Alamos Diagnostics · Nov 1987
K881877 · COBAS EIA(TM) PHOTOMETER
Download PDF Roche Diagnostic Syst…