Cleared Traditional

K953437 - OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBI...

K953437 is the FDA 510(k) clearance for OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBI... by Olympus America, Inc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953437 · Olympus America, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
91d
Days
Class 1
Risk

K953437 is an FDA 510(k) clearance for the OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - 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 Olympus America, Inc. devices

Submission Details

510(k) Number K953437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1995
Decision Date October 20, 1995
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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 - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 18
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K953437.
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323
K052645 · Ortho-Clinical Diagnostics · Dec 2005
TURBIQUANT ASL
K915742 · Behring Diagnostics, Inc. · Jun 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · Beckman Instruments, Inc. · Jun 1993
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053 · Beckman Instruments, Inc. · Mar 1992
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150 · Beckman Instruments, Inc. · Jul 1991
QM300 CALIBRATOR G PACK
K910885 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991