Cleared Traditional

K894159 - OPUS IMMUNOASSAY SYSTEM

K894159 is the FDA 510(k) clearance for OPUS IMMUNOASSAY SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code KHO) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K894159 · Pb Diagnostic Systems, Inc. · Toxicology device
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Aug 1989
Decision
50d
Days
Class 1
Risk

K894159 is an FDA 510(k) clearance for the OPUS IMMUNOASSAY SYSTEM. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2560 - the FDA toxicology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K894159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date August 03, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 24
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K894159.
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · Dynatech Laboratories, Inc. · Mar 1992
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991
DELFIA PLATE FLUOROMETER 1232
K895240 · Pharmacia, Inc. · Oct 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989
PFI-20 POLARIZING FLUORIMETER
K871550 · The Perkin-Elmer Corp. · Jul 1987
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986