Cleared Traditional

K882557 - COULTER CLONE B1 MONOCLONAL ANTIBODY

K882557 is an FDA 510(k) clearance for COULTER CLONE B1 MONOCLONAL ANTIBODY, manufactured by Coulter Immunology. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K882557 · Coulter Immunology · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
85d
Days
Class 2
Risk

K882557 is an FDA 510(k) clearance for the COULTER CLONE B1 MONOCLONAL ANTIBODY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on September 14, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device 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 - K882557

510(k) Number K882557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date September 14, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 113d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K882557.
SYSMEX NE-8000
K883997 · Toa Medical Electronics USA, Inc. · Dec 1988
HEMAT 12
K884006 · Texas Intl. Laboratories, Inc. · Dec 1988
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
K883177 · Texas Intl. Laboratories, Inc. · Nov 1988
HEMATRAK(R) MODEL 590
K882579 · Priority Service Systems · Sep 1988
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
K882612 · Baker Instructions Corp. · Sep 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
K882370 · Toa Medical Electronics USA, Inc. · Aug 1988
K882557 · COULTER CLONE B1 MONOCLONAL ANTIBODY
Download PDF Coulter Immunology