Cleared Abbreviated

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052101 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
23d
Days
Class 2
Risk

K052101 is an FDA 510(k) clearance for the C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 26, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.8165 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number K052101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2005
Decision Date August 26, 2005
Days to Decision 23 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8165
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.