Cleared Traditional

K831271 - ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG

K831271 is the FDA 510(k) clearance for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K831271 · Ortho Diagnostic Systems, Inc. · Hematology device
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Jul 1983
Decision
98d
Days
Class 2
Risk

K831271 is an FDA 510(k) clearance for the ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 98 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K831271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1983
Decision Date July 26, 1983
Days to Decision 98 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
15d faster than avg
Panel avg: 113d · This submission: 98d
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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K831271.
FACS ANALYZER
K840195 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
K833618 · Ortho Diagnostic Systems, Inc. · Jan 1984
COULTER COUNTER MODEL S-PLUS V
K833600 · Coulter Electronics, Inc. · Jan 1984
COULTER-COUNTER #S PLUS IV & LYSE S +D
K823355 · Coulter Electronics, Inc. · Dec 1982
PENETRAK TM
K821186 · Syva Co. · Jun 1982
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · Abbott Laboratories · Jan 1981