Cleared Traditional

K994112 - MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

K994112 is an FDA 510(k) clearance for MANUAL HER-2/NEU MICROTITER ELISA (OSDI..., manufactured by Oncogene Science, Inc.. The device is a Class 2 Immunology device with product code NCW cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K994112 · Oncogene Science, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K994112

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 105d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCW Device Classification - Class 2, Special Controls

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.