Cleared Traditional

RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) (K880576) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880576 · Reagents Applications, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 46
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K880576.
Calcium2
K244042 · Abbott Ireland · Feb 2025
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · HORIBA ABX SAS · Jul 2019
Randox Calcium (Ca)
K182042 · Randox Laboratories, Ltd. · Oct 2018
CALCIUM
K062855 · Abbott Laboratories · Nov 2006
CA
K981578 · Abbott Laboratories · Jun 1998
SIGMA CALCIUM REAGENT
K933678 · Sigma Chemical Co. · Mar 1994