Cleared Traditional

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 (K072901) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072901 · Amdl, Inc. · Immunology device
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Jul 2008
Decision
264d
Days
Class 2
Risk

K072901 is an FDA 510(k) clearance for the AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101. Classified as System, Test, Fibrin/fibrinogen Degradation Products For Monitoring Of Colorectal Cancer (product code NTY), Class II - Special Controls.

Submitted by Amdl, Inc. (Tustin, US). The FDA issued a Cleared decision on July 1, 2008 after a review of 264 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amdl, Inc. devices

Submission Details

510(k) Number K072901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2007
Decision Date July 01, 2008
Days to Decision 264 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 104d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTY System, Test, Fibrin/fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition Monitoring Cancer Patients After Therapy For Disease Progression In Conjunction With Other Diagnostic Modalities.
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 Immunology devices follow this clearance model.