Cleared Traditional

K900718 - ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) A...

K900718 is the FDA 510(k) clearance for ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) A... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 128
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
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