Cleared Traditional

K951187 - VARELISA CARDIOLIPIN ABS SCREEN

K951187 is an FDA 510(k) clearance for VARELISA CARDIOLIPIN ABS SCREEN, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K951187 · Elias U.S.A., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
200d
Days
Class 2
Risk

K951187 is an FDA 510(k) clearance for the VARELISA CARDIOLIPIN ABS SCREEN. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on October 2, 1995 after a review of 200 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K951187

510(k) Number K951187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date October 02, 1995
Days to Decision 200 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 105d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MID System, Test, Anticardiolipin Immunological

All 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K951187.
CARDIOLIPIN G EIA TEST SYSTEM
K946215 · Hogan & Hartson · Jan 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · Hogan & Hartson · Jan 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · Hogan & Hartson · Jan 1996
QUANTA LITE IGA ACA (HRP)
K953366 · Inova Diagnostics, Inc. · Sep 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · Inova Diagnostics, Inc. · Aug 1995
QUANTA LITE(TM) IGG (HRP)
K946034 · Inova Diagnostics, Inc. · Jul 1995