Cleared Traditional

K854010 - FRUCTOSAMINE TEST (ROCHE)

K854010 is the FDA 510(k) clearance for FRUCTOSAMINE TEST (ROCHE) by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 813-day FDA review.

K854010 · Roche Diagnostic Systems, Inc. · Chemistry device
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Dec 1987
Decision
813d
Days
Class 2
Risk

K854010 is an FDA 510(k) clearance for the FRUCTOSAMINE TEST (ROCHE). 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 December 22, 1987 after a review of 813 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K854010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date December 22, 1987
Days to Decision 813 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
725d slower than avg
Panel avg: 88d · This submission: 813d
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 K854010.
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · Helena Laboratories · May 1988
GLYCO-PROBE GSP
K873428 · Isolab, Inc. · Apr 1988
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986