Cleared Traditional

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) (K971152) - FDA 510(k) Clearance

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

K971152 · Abbott Laboratories · Hematology device
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Aug 1997
Decision
137d
Days
Class 2
Risk

K971152 is an FDA 510(k) clearance for the ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 137 days - within the typical 510(k) review window.

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 K971152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date August 12, 1997
Days to Decision 137 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
24d slower than avg
Panel avg: 113d · This submission: 137d
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 K971152.
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · Abbott Laboratories · Jun 1998
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K980614 · Abbott Laboratories · Apr 1998
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · Abbott Laboratories · Sep 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · Ortho Diagnostic Systems, Inc. · Jul 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
K951632 · Ortho Diagnostic Systems, Inc. · Mar 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · Ortho Diagnostic Systems, Inc. · Jan 1997