Cleared Traditional

ADD OF RETICULOCYTE COUNT/CAPABILITIES (K800533) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800533 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
28d
Days
Class 2
Risk

K800533 is an FDA 510(k) clearance for the ADD OF RETICULOCYTE COUNT/CAPABILITIES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 4, 1980 after a review of 28 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.

View all Abbott Laboratories devices

Submission Details

510(k) Number K800533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1980
Decision Date April 04, 1980
Days to Decision 28 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
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K800533.
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
K831271 · Ortho Diagnostic Systems, Inc. · Jul 1983
PENETRAK TM
K821186 · Syva Co. · Jun 1982
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · Abbott Laboratories · Jan 1981
TECHNICON C/90 SYSTEM
K800121 · Technicon Instruments Corp. · Feb 1980
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · Abbott Laboratories · Aug 1977