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Calcium Procedure, Tekpoint Direct

by Icn Pharmaceuticals, Inc. 510(k)

Active United States

510(k) K770449

Overview

The Calcium Procedure, Tekpoint Direct is a chemical reagent system classified under Clinical Chemistry, designed for the quantitative determination of calcium levels in serum or plasma samples. It employs the cresolphthalein complexone method, a colorimetric assay that measures calcium concentration by forming a colored complex with the reagent, enabling precise analytical results in laboratory settings.

This device is supplied as a ready-to-use reagent system and is intended for single-use in clinical chemistry laboratories. It is not sterile and is classified as a Class II medical device under FDA regulations, with a 510(k) clearance (K770449) granted in 1977. Storage conditions and specific lot sizes are not detailed in the regulatory data, but compliance with standard laboratory reagent handling protocols is implied. The device is regulated under FDA regulation number 862.1145 and falls under the product code CIC.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770449 Date3 May 1977ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Calcium Procedure, Tekpoint Direct used for?

    The Calcium Procedure, Tekpoint Direct is designed for the quantitative determination of calcium levels in serum or plasma samples. It employs the cresolphthalein complexone method, a colorimetric assay that measures calcium concentration by forming a colored complex with the reagent. This allows laboratories to obtain precise analytical results for clinical chemistry testing.

  • How is the Calcium Procedure, Tekpoint Direct supplied?

    This device is supplied as a ready-to-use reagent system, meaning it is pre-mixed and prepared for immediate use in clinical chemistry laboratories. It is intended for single-use only, ensuring accuracy and consistency per test.

  • Is the Calcium Procedure, Tekpoint Direct sterile?

    No, the Calcium Procedure, Tekpoint Direct is not sterile. It is classified as a non-sterile reagent system intended for use in laboratory settings where standard aseptic techniques are applied to prevent contamination.

  • What regulatory clearance does the Calcium Procedure, Tekpoint Direct hold?

    The Calcium Procedure, Tekpoint Direct holds FDA 510(k) clearance under the classification of a Class II medical device. The clearance number is K770449, and it was granted in 1977. This device is regulated under FDA regulation number 862.1145 and falls under the product code CIC.

  • What are the storage requirements for the Calcium Procedure, Tekpoint Direct?

    While specific storage conditions (e.g., temperature, humidity) are not detailed in the regulatory data, the device should be handled in accordance with standard laboratory reagent protocols. This typically includes storing reagents in a clean, dry environment, away from direct light and extreme temperatures, to maintain their integrity and accuracy.