Cleared Special

K994045 - PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

K994045 is an FDA 510(k) clearance for PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LE..., manufactured by Primus Corp.. The device is a Class 2 Hematology device with product code LCP cleared through the Special 510(k) pathway after a 22-day FDA review.

K994045 · Primus Corp. · Hematology device
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Dec 1999
Decision
22d
Days
Class 2
Risk

K994045 is an FDA 510(k) clearance for the PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2. 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 December 21, 1999 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K994045

510(k) Number K994045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1999
Decision Date December 21, 1999
Days to Decision 22 days
Submission Type Special
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
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 248
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K994045.
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · Genzyme Corp. · Mar 2000
HEMOCHEK-A1C SAMPLE COLLECTION KIT
K990899 · Osborn Group, Inc. · Dec 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · Pointe Scientific, Inc., · Dec 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · A.P. Total Care, Inc. · Dec 1999
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850 · Biosafe Laboratories, Inc. · Nov 1999
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
K992921 · Primus Corp. · Nov 1999
K994045 · PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
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