Cleared Traditional

SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) - FDA 510(k) Clearance

Class I Microbiology device.

K974262 · Scantibodies Laboratory, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
41d
Days
Class 1
Risk

K974262 is an FDA 510(k) clearance for the SYSCOS IDC - G, IDC, BSC, IDC - G. Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on December 24, 1997 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scantibodies Laboratory, Inc. devices

Submission Details

510(k) Number K974262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1997
Decision Date December 24, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJX Kit, Serological, Positive Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.