Cleared Traditional

K010334 - WAKO LIPID CALIBRATOR

K010334 is an FDA 510(k) clearance for WAKO LIPID CALIBRATOR, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code JIT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K010334 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
143d
Days
Class 2
Risk

K010334 is an FDA 510(k) clearance for the WAKO LIPID CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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 - K010334

510(k) Number K010334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date June 25, 2001
Days to Decision 143 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 105d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 215
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K010334.
STRATUS CS TROPONIN I CALIBRATOR
K012233 · Dade Behring, Inc. · Sep 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · Roche Diagnostics Corp. · Aug 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · Wako Chemicals USA, Inc. · Aug 2001
RAICHEM CREATININE URINE STANDARD
K011126 · Hemagen Diagnostics, Inc. · May 2001
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc. · Apr 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · Dade Behring, Inc. · Mar 2001