Cleared Traditional

K010332 - WAKO IMMUNOASSAY CALIBRATOR SET

K010332 is an FDA 510(k) clearance for WAKO IMMUNOASSAY CALIBRATOR SET, 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 180-day FDA review.

K010332 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
180d
Days
Class 2
Risk

K010332 is an FDA 510(k) clearance for the WAKO IMMUNOASSAY CALIBRATOR SET. 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 August 1, 2001 after a review of 180 days - an extended review cycle.

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 - K010332

510(k) Number K010332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date August 01, 2001
Days to Decision 180 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
75d slower than avg
Panel avg: 105d · This submission: 180d
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 K010332.
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · Nichols Institute Diagnostics · Oct 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · Dade Behring, Inc. · Sep 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · Roche Diagnostics Corp. · Aug 2001
WAKO LIPID CALIBRATOR
K010334 · Wako Chemicals USA, Inc. · Jun 2001
RAICHEM CREATININE URINE STANDARD
K011126 · Hemagen Diagnostics, Inc. · May 2001
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc. · Apr 2001