IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

• K Number: K013566
• Device Name: IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
• Manufacturer: DIAGNOSTIC PRODUCTS CORP.
• Date Cleared: 2001-11-20 ( 25 days)
• Product Code: CEW
• Regulation Number: 862.1545
• Type: Special
• Panel: CH
• Reference & Predicate Devices: K011505
• Predicate For: N/A

Intended Use

The IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH assays are for in vitro diagnostic use with their respective analyzers for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Device Description

IMMULITE Intact PTH and IMMULITE 2000 Intact PTH are solid phase, chemiluminescent enzyme immunometric assays for use with their respective IMMULITE and IMMULITE 2000 Automated Analyzers.

AI/ML Overview

The provided document is a 510(k) summary for the IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH devices. It describes the device, its intended use, and technology, but does not contain acceptance criteria or detailed study results demonstrating performance against such criteria. It states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration has reviewed in its determination of substantial equivalence for IMMULITE Intact PTH and IMMULITE 2000 Intact PTH," but then does not present any of that data.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is missing from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily focuses on the regulatory submission and classification of the device, rather than detailed performance study outcomes.

Regulation Number and Section

§ 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.