ACTIVE INTACT PTH

• K Number: K973514
• Device Name: ACTIVE INTACT PTH
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1997-10-31 ( 44 days)
• Product Code: CEW
• Regulation Number: 862.1545
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination of I-PTH in human serum. This assay is intended for in vitro diagnostic use. 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

The DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit was developed for the quantitative measurement of the intact molecule PTH in human serum. This Coated Bead IRMA format is a capture assay. Goat polyclonal antibody to PTH is immobilized to the surface of the coated bead. I-PTH in the standards or serum samples is "sandwiched" between this polyclonal antibody and the anti-I-PTH goat polyclonal antibody radiolabeled for detection with I-125.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA Kit, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device: DSL 8000 ACTIVE™ I-PTH IRMA. The study aimed to demonstrate that the new device measures I-PTH levels with a strong correlation and similar performance to the established predicate device, using patient samples that span the expected range of I-PTH values.	Linear regression analysis of results from 97 patient samples comparing the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit (Y) to the DSL 8000 ACTIVE™ I-PTH IRMA (X) yielded the equation: Y = 0.93(X) + 33.81 with a correlation coefficient (r) = 0.97.

Study Details:

1. Sample Size used for the test set and data provenance:

   • Sample Size: 97 patient samples.
   • Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, the samples were "patient samples" chosen to represent low, intermediate, and high I-PTH levels.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for this equivalence study was the measurement obtained from the predicate device (DSL 8000 ACTIVE™ I-PTH IRMA), not expert interpretation of the samples themselves.

3. Adjudication method for the test set:

   • Not applicable. The study compares quantitative measurements from two devices rather than expert adjudication.

4. 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:

   • No. This was a device-to-device equivalence study, not an MRMC study involving human readers or AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense. The study evaluated the performance of the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit itself against another device (the predicate). There is no "human-in-the-loop" component in the direct measurement of I-PTH by these IRMA kits.

6. The type of ground truth used:

   • Comparative Ground Truth: The measurements obtained from the predicate device, the DSL 8000 ACTIVE™ I-PTH IRMA. The assumption is that the predicate device provides accurate measurements of I-PTH.

7. The sample size for the training set:

   • Not applicable. This document describes a validation study for substantial equivalence, not the development or training of the assay itself. The assay is a "Coated Bead IRMA kit," which implies a biochemical measurement system, not a machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there was no explicit "training set" for the assay described in this document. The assay's underlying principles are based on immunoradiometric assay technology.

Summary

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K973514

145 Medical Center Boulevard Vabster Texas 77598-4217 USA Tel [phone] 554.4220

OCT 3 1 1997

Tel [phone] Fax [phone] Email [e-mail]

SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: Classification Name: Analvte Name: Requlatory Class:

DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA Kit Immunoradiometric Assay, I-PTH Intact Parathyroid Hormone 11

Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: [phone]

September 16, 1997 Date:

The DSL ACTIVE™ I-PTH Coated Bead IRMA kit was developed for the quantitative measurement of the intact molecule PTH in human serum. This Coated Bead IRMA format is a capture assay. Goat polyclonal antibody to PTH is immobilized to the surface of the coated bead. I-PTH in the standards or serum samples is "sandwiched" between this polyclonal antibody and the anti-I-PTH goat polyclonal antibody radiolabeled for detection with I-125.

The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination of I-PTH in human serum. This assay is intended for in vitro diagnostic use. 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.

The DSL ACTIVE™ I-PTH Coated Bead IRMA is substantially equivalent to the DSL 8000 ACTIVE™ I-PTH IRMA. Both kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n = 97) were collected and assayed simultaneously by both methods. Samples were chosen based on expected I-PTH levels so that samples with low, intermediate and high levels of I-PTH would be evaluated. Linear regression analysis of the results obtained for the comparison with the I-PTH assay gave the equation Y = 0.93(X) + 33.81 with a correlation coefficient of (r) = 0.97.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 3 1 1997

John Willis . Director of Requlatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598

Re: K973514 DSL 9300 ACTIVE I-PTH Coated Bead IRMA Kit Requlatory Class: II Product Code: CEW Dated: September 16, 1997 Received: September 17, 1997

Dear Mr. Willis:

requlations.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ACTIVE™ Intact PTH IRMA

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*escription Use Per 21 CFR 801.109)

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Over-The-Counter Use

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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.