Cleared Traditional

K030655 - HOLOTC RIA

K030655 is the FDA 510(k) clearance for HOLOTC RIA by Axis-Shield Biochemicals, Asa. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K030655 · Axis-Shield Biochemicals, Asa · Chemistry device
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Jan 2004
Decision
332d
Days
Class 2
Risk

K030655 is an FDA 510(k) clearance for the HOLOTC RIA. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Axis-Shield Biochemicals, Asa (San Diego, US). The FDA issued a Cleared decision on January 29, 2004 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Axis-Shield Biochemicals, Asa devices

Submission Details

510(k) Number K030655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date January 29, 2004
Days to Decision 332 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 88d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K030655.
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · Roche Diagnostics Corp. · Apr 2006
ABBOTT AXSYM B12
K051327 · Abbott Laboratories · Aug 2005
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · Bayer Healthcare, LLC · Jul 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
K013899 · Ortho-Clinical Diagnostics · Jan 2002
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
K984321 · Ortho-Clinical Diagnostics, Inc. · Jan 1999