Cleared Traditional

K880576 - RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)

K880576 is an FDA 510(k) clearance for RAICHEM(TM) CALCIUM REAGENT (SINGLE STA..., manufactured by Reagents Applications, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K880576

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.

CJY Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K880576.
HI CHEM CALCIUM REAGENT #88808
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K890302 · Data Medical Associates, Inc. · Feb 1989
ROCHE REAGENT FOR CALCIUM
K883453 · Roche Diagnostic Systems, Inc. · Oct 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · Advanced Biomedical Methods, Inc. · Apr 1988
ULTRACHEM CA, ITEM #64975
K813040 · Harleco · Nov 1981
CALCIUM SET, ITEM NO. 65004
K771928 · Harleco · Nov 1977