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K Number
K031534
Device Name
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
Manufacturer
SCANTIBODIES LABORATORY, INC.
Date Cleared
2003-07-30

(75 days)

Product Code
CEW
Regulation Number
862.1545
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Device Description

Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document discusses:

  • The device name: Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay
  • Regulation Number and Name: 21 CFR 862.1545, Parathyroid hormone test system
  • Regulatory Class: Class II
  • Intended Use: To measure PTH levels in serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia.
  • The 510(k) number: K031534

It does not provide details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

§ 862.1545 Parathyroid hormone test system.

(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.