Cleared Traditional

K971503 - MYCOPLASMA IGM ELISA TEST SYSTEM

K971503 is an FDA 510(k) clearance for MYCOPLASMA IGM ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code LJZ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K971503 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
118d
Days
Class 1
Risk

K971503 is an FDA 510(k) clearance for the MYCOPLASMA IGM ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - 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.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K971503

510(k) Number K971503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1997
Decision Date August 20, 1997
Days to Decision 118 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 102d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

LJZ Device Classification - Class 1, General Controls

Product Code LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
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 - LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Devices cleared under the same product code (LJZ) and FDA review panel - the closest regulatory comparables to K971503.
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · Zeus Scientific, Inc. · Jan 1999
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · Zeus Scientific, Inc. · Jun 1997
IMMUNOCARD MYCOPLASMA
K934550 · Meridian Diagnostics, Inc. · Sep 1994
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · Medical Diagnostic Technologies, Inc. · Jun 1992
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
K904501 · Medical Diagnostic Technologies, Inc. · Feb 1991