Cleared Traditional

K942009 - PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

K942009 is an FDA 510(k) clearance for PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBI..., 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 142-day FDA review.

K942009 · Primus Corp. · Hematology device
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Sep 1994
Decision
142d
Days
Class 2
Risk

K942009 is an FDA 510(k) clearance for the PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY. 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 September 14, 1994 after a review of 142 days - within the typical 510(k) review window.

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: 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 Primus Corp. devices

FDA 510(k) Submission Details - K942009

510(k) Number K942009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date September 14, 1994
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
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 203
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K942009.
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · Heraeus Kulzer, Inc. · May 1995
VARIANT TOTAL GHB PROGRAM
K941616 · Bio-Rad · Apr 1995
TINA-QUANT HEMOGLOBIN A1C
K934070 · Boehringer Mannheim Corp. · Oct 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · Heraeus Kulzer, Inc. · Jul 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · Bio-Rad · Apr 1994
GLYCOHEMOGLOBIN
K931183 · Teco Diagnostics · Nov 1993