Cleared Traditional

K952466 - OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIM...

K952466 is the FDA 510(k) clearance for OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIM... by Olympus America, Inc.. It is a Class 1 Immunology device (product code JHN) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K952466 · Olympus America, Inc. · Immunology device
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Jun 1995
Decision
10d
Days
Class 1
Risk

K952466 is an FDA 510(k) clearance for the OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT. Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - the FDA immunology 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 Olympus America, Inc. devices

Submission Details

510(k) Number K952466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1995
Decision Date June 05, 1995
Days to Decision 10 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 104d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHN Turbidimetric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - JHN Turbidimetric Method, Lipoproteins

Devices cleared under the same product code (JHN) and FDA review panel - the closest regulatory comparables to K952466.
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
K950383 · Randox Laboratories, Ltd. · Sep 1995
WAKO AUTOKIT APO A1
K952615 · Wako Chemicals USA, Inc. · Sep 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425 · Olympus America, Inc. · Jul 1995
APOLIPOPROTIEN B (APO B)
K932603 · Sigma Diagnostics, Inc. · Jun 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · Sigma Diagnostics, Inc. · Jun 1994