Cleared Traditional

K100547 - ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL

K100547 is an FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS HBA1C REAGENT, manufactured by Seppim S.A.S.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K100547 · Seppim S.A.S. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
448d
Days
Class 2
Risk

K100547 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRAT.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on May 19, 2011 after a review of 448 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.

FDA 510(k) Submission Details - K100547

510(k) Number K100547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2010
Decision Date May 19, 2011
Days to Decision 448 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 88d · This submission: 448d
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 235
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K100547.
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DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
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DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 2011
AFINION ANALYZER
K110056 · Axis-Shield Poc AS · Feb 2011
K100547 · ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
Download PDF FDA Summary Seppim S.A.S.