Cleared Traditional

K881877 - COBAS EIA(TM) PHOTOMETER

K881877 is the FDA 510(k) clearance for COBAS EIA(TM) PHOTOMETER by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (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.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 115
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K881877.
BEHRING TURBITIMER
K883646 · Behring Diagnostics, Inc. · Oct 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · Behring Diagnostics, Inc. · Aug 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · Dynatech Laboratories, Inc. · Nov 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219 · Gen-Probe, Inc. · Aug 1987