Data Zyme Acid Phosphatase Procedure

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850902 ↗

FDA Product Code

CKB

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

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• What clinical conditions does the Data-Zyme Acid Phosphatase Procedure help evaluate?

  This procedure quantifies serum or plasma acid phosphatase levels to assist in diagnosing prostate disorders (such as prostate cancer), monitoring bone metabolism, and evaluating lysosomal storage diseases. Elevated or abnormal levels can indicate underlying pathological conditions, making it a valuable tool for clinicians assessing these specific clinical scenarios.

• How is the Data-Zyme Acid Phosphatase Procedure supplied, and what storage conditions are required?

  The device is supplied as a reagent kit designed for single-use per batch. To maintain stability and ensure accurate results, it must be stored at controlled temperatures as specified in the manufacturer’s instructions. Improper storage could compromise reagent integrity and diagnostic reliability.

• Is the Data-Zyme Acid Phosphatase Procedure intended for single-use or reusable applications?

  This procedure is explicitly designed for single-use per batch. Reusing the reagent kit violates manufacturer guidelines and could lead to inaccurate test results, cross-contamination, or compromised sterility. Laboratories must adhere to single-use protocols to ensure diagnostic validity.

• What regulatory pathway does the Data-Zyme Acid Phosphatase Procedure follow, and what does this mean for users?

  The procedure is authorized under FDA 510(k) clearance (K790524) and classified as a Class II medical device (Regulation 862.1020). This means it has undergone review by the FDA’s Clinical Chemistry advisory committee to ensure safety and effectiveness for its intended use in measuring acid phosphatase levels in clinical chemistry settings.

• Are there specific model or reference numbers associated with this reagent kit?

  The Data-Zyme Acid Phosphatase Procedure is identified by its FDA clearance number (K790524) and product code (CKB). These identifiers distinguish it from other similar diagnostic reagents and are referenced in regulatory filings. Laboratories should verify compatibility with their existing clinical chemistry systems before use.