IMMULITE Turbo Intact PTH, Model LSKPTZ

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K992105 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the IMMULITE Turbo Intact PTH, Model LSKPTZ, used for?

  The IMMULITE Turbo Intact PTH, Model LSKPTZ, is designed for the quantitative measurement of intact parathyroid hormone (PTH) in human serum or EDTA plasma. PTH plays a critical role in regulating calcium and bone metabolism, so this assay helps diagnose conditions related to these processes, such as hyperparathyroidism or hypoparathyroidism.

• How is the IMMULITE Turbo Intact PTH, Model LSKPTZ, supplied and intended for use?

  This device is supplied as an in-vitro diagnostic test kit intended for single-use in clinical laboratory settings. It is specifically designed to operate on the IMMULITE Automated Analyzer, ensuring precise diagnostic results without requiring additional sterilization beyond standard laboratory protocols.

• Is the IMMULITE Turbo Intact PTH, Model LSKPTZ, reusable or single-use?

  The IMMULITE Turbo Intact PTH, Model LSKPTZ, is explicitly intended for single-use only. It is not designed for reuse, and its use is restricted to clinical laboratory environments where single-use protocols are standard.

• What type of sample can be tested with the IMMULITE Turbo Intact PTH, Model LSKPTZ?

  This assay is compatible with human serum or EDTA plasma samples. EDTA plasma is often preferred in clinical settings to prevent coagulation and preserve sample integrity for accurate PTH measurement.

• Does the IMMULITE Turbo Intact PTH, Model LSKPTZ, require any special storage conditions?

  While the provided data does not specify exact storage conditions, the device is intended for use in clinical laboratory settings with standard protocols. It is recommended to follow manufacturer guidelines for storage, including temperature and humidity control, to maintain assay integrity and performance.