Cleared Traditional

K900887 - ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM...

K900887 is an FDA 510(k) clearance for ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM..., manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGZ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K900887 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
78d
Days
Class 2
Risk

K900887 is an FDA 510(k) clearance for the ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K900887

510(k) Number K900887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1990
Decision Date May 15, 1990
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGZ Electrode, Ion-specific, Chloride

All 24
Devices cleared under the same product code (CGZ) and FDA review panel - the closest regulatory comparables to K900887.
NOVA 13 ANALYZER, MODIFICATION
K924864 · Nova Biomedical Corp. · Nov 1992
NOVA 13 ANALYZER
K912561 · Nova Biomedical Corp. · Sep 1991
ISE/CI-
K912647 · Boehringer Mannheim Corp. · Jul 1991
OLYMPUS ISE MODULE FOR AU5000
K893628 · Olympus Corp. · Aug 1989
OLYMPUS ISE MODULE
K885193 · Olympus Corp. · Feb 1989
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
K861669 · Data Medical Associates, Inc. · May 1986