Cleared Traditional

K952615 - WAKO AUTOKIT APO A1

K952615 is an FDA 510(k) clearance for WAKO AUTOKIT APO A1, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Immunology device with product code JHN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K952615 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
94d
Days
Class 1
Risk

K952615 is an FDA 510(k) clearance for the WAKO AUTOKIT APO A1. Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K952615

510(k) Number K952615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date September 08, 1995
Days to Decision 94 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
11d faster than avg
Panel avg: 105d · This submission: 94d
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 K952615.
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
K950382 · Randox Laboratories, Ltd. · Sep 1995
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
K950383 · Randox Laboratories, Ltd. · 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