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Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)

by Hitachi Chemical Diagnostics, Inc.

510(k) K130870

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130870 Date2 May 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CIC
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA) is a reagent cartridge designed for the quantitative determination of calcium levels in serum, lithium heparinized plasma, and sodium citrate plasma. It employs the cresolphthalein complexone (OCPC) method to form a purple-red complex with calcium, enabling precise measurement of its concentration in clinical samples.

This cartridge is intended for use exclusively with the Hitachi Clinical Analyzer E40 and is supplied as a single-use disposable. Authorized for clinical chemistry applications, it adheres to FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent. The device is classified under FDA device class II and regulated under regulation number 862.1145.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium?

    This cartridge is designed for the quantitative determination of calcium levels in serum, lithium heparinized plasma, and sodium citrate plasma using the cresolphthalein complexone method to form a purple-red complex with calcium.

  • Which analyzer is compatible with this calcium test reagent cartridge?

    The cartridge is intended for exclusive use with the Hitachi Clinical Analyzer E40 and should not be used with any other analyzer model.

  • Is this reagent cartridge single-use or reusable?

    The Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium is supplied as a single-use disposable cartridge and should not be reused for multiple tests.

  • What regulatory pathway was used for this device?

    The device received FDA 510(k) clearance under the Traditional pathway with a decision classification of Substantially Equivalent and is classified under FDA device class II.