Cleared Traditional

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) (K994112) - FDA 510(k) Clearance

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

K994112 · Oncogene Science, Inc. · Immunology device
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Sep 2000
Decision
298d
Days
Class 2
Risk

K994112 is an FDA 510(k) clearance for the MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA). Classified as System, Test, Her-2/neu, Monitoring (product code NCW), Class II - Special Controls.

Submitted by Oncogene Science, Inc. (Cambridge, US). The FDA issued a Cleared decision on September 29, 2000 after a review of 298 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 Oncogene Science, Inc. devices

Submission Details

510(k) Number K994112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date September 29, 2000
Days to Decision 298 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
194d slower than avg
Panel avg: 104d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NCW System, Test, Her-2/neu, Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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.