Cleared Traditional

K080618 - DIRECT HBA1C

K080618 is the FDA 510(k) clearance for DIRECT HBA1C by Jas Diagnostics, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K080618 · Jas Diagnostics, Inc. · Chemistry device
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May 2008
Decision
79d
Days
Class 2
Risk

K080618 is an FDA 510(k) clearance for the DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jas Diagnostics, Inc. devices

Submission Details

510(k) Number K080618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2008
Decision Date May 23, 2008
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K080618.
DIMENSIONS HB1C KIT, MODEL DF105A
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K090413 · Bayer Healthcare, LLC · May 2009
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734 · Diazyme Laboratories · Apr 2007