Cleared Traditional

K920397 - REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT

K920397 is an FDA 510(k) clearance for REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE ..., manufactured by Medical Analysis Systems, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K920397 · Medical Analysis Systems, Inc. · Chemistry device
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Aug 1992
Decision
187d
Days
Class 2
Risk

K920397 is an FDA 510(k) clearance for the REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on August 4, 1992 after a review of 187 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 Medical Analysis Systems, Inc. devices

FDA 510(k) Submission Details - K920397

510(k) Number K920397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date August 04, 1992
Days to Decision 187 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 88d · This submission: 187d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K920397.
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MODIFICATION COLUMNMATE
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COLUMNMATE II
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K921305 · Helena Laboratories · Jun 1992