Cleared Traditional

K950382 - APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT

K950382 is the FDA 510(k) clearance for APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT by Randox Laboratories, Ltd.. It is a Class 1 Chemistry device (product code JHN) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K950382 · Randox Laboratories, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
227d
Days
Class 1
Risk

K950382 is an FDA 510(k) clearance for the APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT. Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on September 15, 1995 after a review of 227 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K950382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date September 15, 1995
Days to Decision 227 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
139d slower than avg
Panel avg: 88d · This submission: 227d
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 K950382.
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
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466 · Olympus America, Inc. · Jun 1995
APOLIPOPROTIEN B (APO B)
K932603 · Sigma Diagnostics, Inc. · Jun 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · Sigma Diagnostics, Inc. · Jun 1994