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Raichem Acid Phosphatase Reagent

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K831834

Overview

The Raichem Acid Phosphatase Reagent is a diagnostic reagent classified under the nomenclature for Acid Phosphatase, Naphthyl Phosphate, used in clinical chemistry assays. It functions as a substrate reagent for quantifying acid phosphatase activity in biological samples, aiding in the diagnosis and monitoring of conditions such as prostate disorders, bone diseases, and metabolic disorders.

This reagent is supplied as a dry powder intended for reconstitution with distilled water prior to use. It is classified as a Class II medical device under FDA regulations (21 CFR 862.1020) and holds a Traditional 510(k) clearance (K831834) with a Substantially Equivalent determination by the Clinical Chemistry (CH) Advisory Committee. The product is non-sterile, single-use, and must be stored according to the label instructions until expiration.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831834 Date26 Aug 1983ClearedStatusActive

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)

Full name
Raichem Acid Phasphatase Reagent
510(k) Number
FDA Product Code
CKB
Device Class
Class II
Regulation
21 CFR Part 862.1020
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Raichem Acid Phosphatase Reagent used for in clinical practice?

    The Raichem Acid Phosphatase Reagent is designed for use in clinical chemistry assays to quantify acid phosphatase activity in biological samples. This helps in diagnosing and monitoring conditions such as prostate disorders, bone diseases, and metabolic disorders by measuring enzyme levels in patient specimens.

  • How is the Raichem Acid Phosphatase Reagent supplied and prepared for use?

    The reagent is supplied as a dry powder that must be reconstituted with distilled water before use. It is intended for single-use only, so each vial should be prepared fresh for one assay session.

  • Is the Raichem Acid Phosphatase Reagent sterile, and what storage instructions apply?

    The reagent is explicitly labeled as non-sterile, so it should not be used in sterile procedures. It must be stored according to the label instructions until its expiration date to maintain integrity.

  • What regulatory pathway was followed for FDA clearance of this product?

    The Raichem Acid Phosphatase Reagent received a Traditional 510(k) clearance (K831834) through the FDA’s Clinical Chemistry (CH) Advisory Committee, with a determination of Substantially Equivalent to a predicate device. The classification under 21 CFR 862.1020 confirms it as a Class II medical device.

  • Can this reagent be reused after reconstitution, or is it strictly single-use?

    The product is explicitly labeled as single-use after reconstitution. Once prepared, it should not be reused, as this could compromise accuracy and patient safety.