Cleared Traditional

K952287 - REAADS ANTI-PHOSPHATIDYLSERINE QUANTITA...

K952287 is the FDA 510(k) clearance for REAADS ANTI-PHOSPHATIDYLSERINE QUANTITA... by Reaads Medical Products, Inc.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K952287 · Reaads Medical Products, Inc. · Immunology device
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Dec 1995
Decision
216d
Days
Class 2
Risk

K952287 is an FDA 510(k) clearance for the REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Reaads Medical Products, Inc. (Westminister, US). The FDA issued a Cleared decision on December 18, 1995 after a review of 216 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 Reaads Medical Products, Inc. devices

Submission Details

510(k) Number K952287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date December 18, 1995
Days to Decision 216 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 104d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K952287.
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · Zeus Scientific, Inc. · Jul 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · Immco Diagnostics, Inc. · Jun 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc. · Jun 1997
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · Elias U.S.A., Inc. · Oct 1995
QUANTA LITE IGA ACA (HRP)
K953366 · Inova Diagnostics, Inc. · Sep 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · Inova Diagnostics, Inc. · Aug 1995