Cleared Traditional

K915053 - BECKMAN ANTISTREPTOLYSIN O

K915053 is an FDA 510(k) clearance for BECKMAN ANTISTREPTOLYSIN O, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K915053 · Beckman Instruments, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
140d
Days
Class 1
Risk

K915053 is an FDA 510(k) clearance for the BECKMAN ANTISTREPTOLYSIN O, MODIFICATION. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 140 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K915053

510(k) Number K915053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date March 19, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

GTQ Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K915053.
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · Olympus America, Inc. · Oct 1995
TURBIQUANT ASL
K915742 · Behring Diagnostics, Inc. · Jun 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · Beckman Instruments, Inc. · Jun 1993
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
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991