Cleared Traditional

K991274 - MUMPS IGG ELISA TEST SYSTEM

K991274 is an FDA 510(k) clearance for MUMPS IGG ELISA TEST SYSTEM, manufactured by Columbia Bioscience, Inc.. The device is a Class 1 Microbiology device with product code LJY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K991274 · Columbia Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
143d
Days
Class 1
Risk

K991274 is an FDA 510(k) clearance for the MUMPS IGG ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Mumps Virus (product code LJY), Class I - General Controls.

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3380 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K991274

510(k) Number K991274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date September 03, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 102d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

LJY Device Classification - Class 1, General Controls

Product Code LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
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.

Regulatory Peers - LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus

Devices cleared under the same product code (LJY) and FDA review panel - the closest regulatory comparables to K991274.
SERAQUEST MUMPS IGG
K980059 · Quest Intl., Inc. · Apr 1998
MUMPS IGG ELISA TESTY
K971857 · Gull Laboratories, Inc. · Nov 1997
MUMPS IGG TEST
K961204 · Zeus Scientific, Inc. · Jul 1996
MUMPS STAT
K925209 · Biowhittaker Molecular Applications, Inc. · Oct 1994
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
K923903 · Biomerieux Vitek, Inc. · Aug 1993
PHARMACIA MUMPS IGG ELISA
K897006 · Pharmacia Eni Diagnostics, Inc. · Jul 1990
K991274 · MUMPS IGG ELISA TEST SYSTEM
Download PDF FDA Summary Columbia Bioscience, …