Cleared Traditional

K964787 - MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM

K964787 is an FDA 510(k) clearance for MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM ..., manufactured by Mardx Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K964787 · Mardx Diagnostics, Inc. · Immunology device
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Apr 1997
Decision
130d
Days
Class 2
Risk

K964787 is an FDA 510(k) clearance for the MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Mardx Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Mardx Diagnostics, Inc. devices

FDA 510(k) Submission Details - K964787

510(k) Number K964787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date April 08, 1997
Days to Decision 130 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
25d slower than avg
Panel avg: 105d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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.

Regulatory Peers - LLL Extractable Antinuclear Antibody, Antigen And Control

All 143
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K964787.
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K980639 · Quest Intl., Inc. · Jun 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · Diamedix Corp. · Apr 1998
IS-ANTI-SSA TEST SYSTEM
K970218 · Diamedix Corp. · Apr 1997
IS-ANTI-SM TEST SYSTEM
K970220 · Diamedix Corp. · Apr 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228 · Diamedix Corp. · Apr 1997