Cleared Traditional

K872051 - CALCIUM CALIBRATOR

K872051 is an FDA 510(k) clearance for CALCIUM CALIBRATOR, 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 113-day FDA review.

K872051 · Wako Chemicals USA, Inc. · Chemistry device
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Sep 1987
Decision
113d
Days
Class 2
Risk

K872051 is an FDA 510(k) clearance for the CALCIUM CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on September 18, 1987 after a review of 113 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 - K872051

510(k) Number K872051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date September 18, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
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 K872051.
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585 · Hichem Diagnostics · Nov 1989
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · Reagents Applications, Inc. · Aug 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · Terumo Medical Corp. · Jun 1988
ISE COMPENSATION SERA
K870379 · Boehringer Mannheim Corp. · Feb 1987
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · Em Diagnostic Systems, Inc. · Aug 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · Em Diagnostic Systems, Inc. · Aug 1986