Cleared Traditional

K011933 - GLYCOSAL II HBA 1C TEST

K011933 is an FDA 510(k) clearance for GLYCOSAL II HBA 1C TEST, manufactured by Provalis Diagnostics , Ltd.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K011933 · Provalis Diagnostics , Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
135d
Days
Class 2
Risk

K011933 is an FDA 510(k) clearance for the GLYCOSAL II HBA 1C TEST. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Provalis Diagnostics , Ltd. (Rockville, US). The FDA issued a Cleared decision on November 2, 2001 after a review of 135 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.

FDA 510(k) Submission Details - K011933

510(k) Number K011933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2001
Decision Date November 02, 2001
Days to Decision 135 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
46d slower than avg
Panel avg: 89d · This submission: 135d
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 247
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K011933 · GLYCOSAL II HBA 1C TEST
Download PDF FDA Summary Provalis Diagnostics …