Cleared Traditional

ABBOTT ENCOUNTER(TM)Q (K930309) - FDA 510(k) Clearance

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

K930309 · Abbott Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
174d
Days
Class 2
Risk

K930309 is an FDA 510(k) clearance for the ABBOTT ENCOUNTER(TM)Q. 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 July 14, 1993 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K930309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date July 14, 1993
Days to Decision 174 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 113d · This submission: 174d
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 124
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K930309.
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
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K932532 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · Ortho Diagnostic Systems, Inc. · Apr 1995
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · Heraeus Kulzer, Inc. · May 1993
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · Heraeus Kulzer, Inc. · May 1992