Cleared Traditional

K101089 - EASYRA MICRO-ALBUMIN REAGENT AND CALIBR...

K101089 is the FDA 510(k) clearance for EASYRA MICRO-ALBUMIN REAGENT AND CALIBR... by Medica Corp.. It is a Class 2 Chemistry device (product code DCF) cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K101089 · Medica Corp. · Chemistry device
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Jul 2011
Decision
450d
Days
Class 2
Risk

K101089 is an FDA 510(k) clearance for the EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on July 13, 2011 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - 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.

View all Medica Corp. devices

Submission Details

510(k) Number K101089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2010
Decision Date July 13, 2011
Days to Decision 450 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
362d slower than avg
Panel avg: 88d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 17
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K101089.
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K061990 · Dade Behring, Inc. · Sep 2006
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K051191 · Diagnostic Chemicals , Ltd. · Jul 2005
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K042643 · Ortho-Clinical Diagnostics, Inc. · Nov 2004