Lumatag Intact PTH Assay

No FDA recalls found in the data synced 6 Oct 2026.

Full name

London Diagnostics Lumatag(Tm) Intact Pth Assay

510(k) Number

K903130 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Lumatag(Tm) Ferritin Chemiluminescence Immunomet.

  Class II

  FDA 510(k) K901075 Active Cleared 2 Apr 1990

• Lumatag Free T4 Chemiluminescence Assay

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  FDA 510(k) K914835 Active Cleared 17 Dec 1991

• Lumatag(R) Fsh Chemiluminescence Immunometri Assay

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• London Diagnostics Lumatag(R) Hgh Chem Immun Assay

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• Lumatag(Tm) Prolactin Chemilumines. Immuno. Assay

  Class I

  FDA 510(k) K880296 Active Cleared 24 Mar 1988

• London Diagnostics Lumatag (R) Ige Chem. Imm Assay

  Class II

  FDA 510(k) K903195 Active Cleared 2 Aug 1990

See all devices from London Diagnostics, Inc. →

• What types of samples can the Lumatag Intact PTH Assay measure, and how is it intended to be used in clinical practice?

  The Lumatag Intact PTH Assay is designed to quantitatively measure intact parathyroid hormone (PTH) levels in serum or plasma samples. It is intended for use in clinical chemistry laboratories to aid in diagnosing and monitoring parathyroid disorders, such as hyperparathyroidism and hypoparathyroidism. Since it is a radioimmunoassay, it requires laboratory processing and is not a point-of-care or bedside test.

• Is the Lumatag Intact PTH Assay intended for single-use, and how should it be stored to maintain sterility?

  Yes, the Lumatag Intact PTH Assay is supplied as a single-use diagnostic kit, meaning each kit is intended for one test procedure only. Sterility is maintained through the manufacturer-provided packaging, and storage should follow standard in vitro diagnostic assay protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures, as outlined in the manufacturer’s instructions.

• What regulatory pathway was followed for FDA clearance of this assay, and what classification does it fall under?

  The Lumatag Intact PTH Assay received FDA 510(k) clearance under the traditional review pathway, with a decision date of September 25, 1990. It is classified as a Class II medical device and falls under the Clinical Chemistry advisory committee (CH). The clearance number is K903130, and it is intended for in vitro diagnostic use.

• Can this assay be used in environments where MRI equipment is present, or does it have any special handling requirements?

  The Lumatag Intact PTH Assay is not intended for use in MRI environments. Since it is a radioimmunoassay, it does not contain MRI-compatible materials, and exposure to magnetic fields could potentially interfere with its performance or safety. Standard laboratory protocols for in vitro diagnostics should be followed, including proper handling and disposal of radioactive materials if applicable.