Cleared Traditional

K936204 - GLYCATED HEMOGLOBIN CALIBRATORS

K936204 is an FDA 510(k) clearance for GLYCATED HEMOGLOBIN CALIBRATORS, manufactured by Primus Corp.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K936204 · Primus Corp. · Hematology device
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Mar 1994
Decision
83d
Days
Class 2
Risk

K936204 is an FDA 510(k) clearance for the GLYCATED HEMOGLOBIN CALIBRATORS. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Primus Corp. (Kansas City, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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.

FDA 510(k) Submission Details - K936204

510(k) Number K936204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 22, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 113d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 247
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K936204.
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
K942009 · Primus Corp. · Sep 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · Heraeus Kulzer, Inc. · Jul 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · Bio-Rad · Apr 1994
GLYCATED HEMOGLOBIN CONTROLS
K940143 · Primus Corp. · Mar 1994
GLYCOHEMOGLOBIN
K931183 · Teco Diagnostics · Nov 1993
745 GLYCOMAT
K933287 · Drew Scientific , Ltd. · Sep 1993
K936204 · GLYCATED HEMOGLOBIN CALIBRATORS
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