Cleared Traditional

K950383 - APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT

K950383 is an FDA 510(k) clearance for APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code JHN cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K950383 · Randox Laboratories, Ltd. · Chemistry device
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Sep 1995
Decision
227d
Days
Class 1
Risk

K950383 is an FDA 510(k) clearance for the APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC 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

FDA 510(k) Submission Details - K950383

510(k) Number K950383 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.

JHN Device Classification - Class 1, General Controls

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 K950383.
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
K950382 · Randox Laboratories, Ltd. · Sep 1995
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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