Cleared Traditional

K831271 - ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG

K831271 is an FDA 510(k) clearance for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K831271

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.

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 295
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