Cleared Traditional

K915650 - HUMAN IGG SUBCLASS RID KIT

K915650 is an FDA 510(k) clearance for HUMAN IGG SUBCLASS RID KIT, manufactured by Janssen Biochimica. The device is a Class 2 Immunology device with product code CGM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K915650 · Janssen Biochimica · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
99d
Days
Class 2
Risk

K915650 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS RID KIT. Classified as Method, Immunodiffusion, Immunoglobulins (g, A, M) (product code CGM), Class II - Special Controls.

Submitted by Janssen Biochimica (Piscataway, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Janssen Biochimica devices

FDA 510(k) Submission Details - K915650

510(k) Number K915650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date March 26, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 105d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGM Device Classification - Class 2, Special Controls

Product Code CGM Method, Immunodiffusion, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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.