Cleared Traditional

K973547 - TRIAGE STATMETER

K973547 is an FDA 510(k) clearance for TRIAGE STATMETER, manufactured by Biosite Incorporated. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K973547 · Biosite Incorporated · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
117d
Days
Class 1
Risk

K973547 is an FDA 510(k) clearance for the TRIAGE STATMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 13, 1998 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K973547

510(k) Number K973547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1997
Decision Date January 13, 1998
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 31
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K973547.
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
K112161 · Radiometer Medical Aps · Jan 2012
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · Tosoh Medics, Inc. · Jun 1997
VITROS IMMUNODIAGNOSTIC SYSTEM
K962919 · Johnson & Johnson Clinical Diagnostics, Inc. · Oct 1996
FLUOROSCAN NEONATAL
K950415 · Isolab, Inc. · Sep 1995
AUTO DELFIA
K935047 · Wallac OY · May 1994
OPUS MAGNUM ANALYZER
K926131 · Pb Diagnostic Systems, Inc. · Jun 1993