Cleared Traditional

K980812 - IMX HOMOCYSTEINE

K980812 is an FDA 510(k) clearance for IMX HOMOCYSTEINE, manufactured by Axis Biochemicals, Asa. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K980812 · Axis Biochemicals, Asa · Chemistry device
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Oct 1998
Decision
212d
Days
Class 2
Risk

K980812 is an FDA 510(k) clearance for the IMX HOMOCYSTEINE. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Axis Biochemicals, Asa (San Diego, US). The FDA issued a Cleared decision on October 1, 1998 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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.

View all Axis Biochemicals, Asa devices

FDA 510(k) Submission Details - K980812

510(k) Number K980812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date October 01, 1998
Days to Decision 212 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
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 37
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