Cleared Traditional

K896582 - DIABETES CARE(TM) TEST PACKAGE FOR THE ...

K896582 is the FDA 510(k) clearance for DIABETES CARE(TM) TEST PACKAGE FOR THE ... by Primus, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K896582 · Primus, Inc. · Chemistry device
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Jun 1990
Decision
223d
Days
Class 2
Risk

K896582 is an FDA 510(k) clearance for the DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM). 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 28, 1990 after a review of 223 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Primus, Inc. devices

Submission Details

510(k) Number K896582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date June 28, 1990
Days to Decision 223 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 88d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K896582.
OPTIMATE HEMOGLOBIN A1C
K896830 · Heraeus Kulzer, Inc. · Sep 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455 · Analytical Control Systems, Inc. · Jul 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
K902457 · Analytical Control Systems, Inc. · Jul 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · Helena Laboratories · Jun 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · Roche Diagnostic Systems, Inc. · Jun 1990
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · Helena Laboratories · Jun 1989