Cleared Traditional

K932437 - EYE SPOT RF TEST

K932437 is an FDA 510(k) clearance for EYE SPOT RF TEST, manufactured by J & S Medical Assoc., Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K932437 · J & S Medical Assoc., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
96d
Days
Class 2
Risk

K932437 is an FDA 510(k) clearance for the EYE SPOT RF TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by J & S Medical Assoc., Inc. (Natick, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 J & S Medical Assoc., Inc. devices

FDA 510(k) Submission Details - K932437

510(k) Number K932437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1993
Decision Date August 23, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 105d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K932437.
N LATEX RF
K942328 · Behring Diagnostics, Inc. · Oct 1994
IGM RHEUMATOID FACTOR
K942272 · Immco Diagnostics, Inc. · Sep 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · Theratest Laboratories, Inc. · Jan 1994
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320 · Trinity Laboratories, Inc. · Dec 1992
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K924036 · J.S. Medical Assoc. · Dec 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992