Cleared Traditional

K963847 - WAKO DIRECT HDL-C

K963847 is an FDA 510(k) clearance for WAKO DIRECT HDL-C, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963847 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
90d
Days
Class 2
Risk

K963847 is an FDA 510(k) clearance for the WAKO DIRECT HDL-C. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K963847

510(k) Number K963847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date December 24, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 112
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K963847.
WAKO BILIRUBIN CALIBRATOR
K993219 · Wako Chemicals USA, Inc. · Nov 1999
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · Beckman Coulter, Inc. · Dec 1998
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · Pointe Scientific, Inc., · May 1997
CLINICAL BLOOD GAS MIXTURES
K964475 · Oxarc, Inc. · Dec 1996
SYNCHRON ENZYME VALIDATOR SET
K951964 · Beckman Instruments, Inc. · Jun 1995
T-UPTAKE CALIBRATORS
K951585 · Diagnostic Reagents, Inc. · Jun 1995