Cleared Traditional

K952719 - BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

K952719 is an FDA 510(k) clearance for BIOCIRCUITS IOS (IN-OFFICE SYSTEM), manufactured by Biocircuits Corp.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K952719 · Biocircuits Corp. · Chemistry device
Download Printable Device Report (PDF)
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Nov 1995
Decision
160d
Days
Class 1
Risk

K952719 is an FDA 510(k) clearance for the BIOCIRCUITS IOS (IN-OFFICE SYSTEM). Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 160 days - an extended review cycle.

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 Biocircuits Corp. devices

FDA 510(k) Submission Details - K952719

510(k) Number K952719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date November 22, 1995
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
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 32
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K952719.
TRIAGE STATMETER
K973547 · Biosite Incorporated · Jan 1998
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