Cleared Traditional

K891235 - PRIMUS MODEL CLC 330

K891235 is an FDA 510(k) clearance for PRIMUS MODEL CLC 330, manufactured by Primus, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K891235 · Primus, Inc. · Hematology device
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Jun 1989
Decision
101d
Days
Class 2
Risk

K891235 is an FDA 510(k) clearance for the PRIMUS MODEL CLC 330. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Primus, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 101 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, Inc. devices

FDA 510(k) Submission Details - K891235

510(k) Number K891235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date June 16, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
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 K891235.
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
K896334 · Creative Laboratory Products, Inc. · Dec 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
K896335 · Creative Laboratory Products, Inc. · Dec 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · Helena Laboratories · Jun 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · Sigma Diagnostics, Inc. · Mar 1989
LABILE LYSING REAGENT
K884315 · Helena Laboratories · Dec 1988
GHB SAMPLE PAPER
K880673 · Isolab, Inc. · Nov 1988