Cleared Traditional

K900718 - ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY

K900718 is an FDA 510(k) clearance for ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K900718 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jun 1990
Decision
118d
Days
Class 2
Risk

K900718 is an FDA 510(k) clearance for the ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 118 days - within the typical 510(k) review window.

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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K900718

510(k) Number K900718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1990
Decision Date June 12, 1990
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 195
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K900718.
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
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