Cleared Traditional

K880576 - RAICHEM(TM) CALCIUM REAGENT (SINGLE STA...

K880576 is the FDA 510(k) clearance for RAICHEM(TM) CALCIUM REAGENT (SINGLE STA... by Reagents Applications, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K880576 · Reagents Applications, Inc. · Chemistry device
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Jun 1988
Decision
121d
Days
Class 2
Risk

K880576 is an FDA 510(k) clearance for the RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID). Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K880576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1988
Decision Date June 10, 1988
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 32
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K880576.
HI CHEM CALCIUM REAGENT #88808
K890584 · Hichem Diagnostics · Apr 1989
CALCIUM PLUS PROCEDURE
K890302 · Data Medical Associates, Inc. · Feb 1989
ROCHE REAGENT FOR CALCIUM
K883453 · Roche Diagnostic Systems, Inc. · Oct 1988
ULTRACHEM CA, ITEM #64975
K813040 · Harleco · Nov 1981
CALCIUM SET, ITEM NO. 65004
K771928 · Harleco · Nov 1977
ULTRACHEM CALCIUM
K770817 · Harleco · Jul 1977