IMMULITE TURBO INTACT PTH, MODEL LSKPTZ by DIAGNOSTIC PRODUCTS CORP.

IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Device Description

IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer, Reagent system for the determination of intact PTH in EDTA plasma or serum.

AI/ML Overview

The provided text describes a 510(k) submission for the IMMULITE® Turbo Intact PTH device, an in vitro diagnostic assay. However, the document does not contain specific acceptance criteria or an explicit study that proves the device meets those criteria in the typical format of a device performance study with acceptance metrics such as sensitivity, specificity, accuracy, or correlation coefficients.

Instead, the document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, as required for 510(k) clearances. This means that the FDA determined the new device is as safe and effective as a previously approved device. The "Conclusion" explicitly states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Intact PTH."

Therefore, based solely on the provided text, it's not possible to answer all aspects of your request as they relate to a direct performance study with defined acceptance criteria. I will address what can be inferred or stated about the device and the regulatory process.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided documents. For an IVD like this, acceptance criteria would typically involve performance characteristics such as analytical sensitivity, specificity, precision (intra-assay, inter-assay), linearity, recovery, and correlation with a predicate device or a gold standard method. These are implied requirements for achieving "substantial equivalence" but not detailed in this summary.
Reported Device Performance: Not explicitly enumerated in a table in the provided text. The submission itself contained data that demonstrated adequate performance for FDA to grant substantial equivalence, but the specific metrics are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified in the provided text.
Data Provenance: Not specified in the provided text. However, since the manufacturer is Diagnostic Products Corporation in Los Angeles, California, and the submission is to the U.S. FDA, it is highly probable that the study data (if clinical samples were used) would primarily come from the United States. Whether it was retrospective or prospective is not mentioned.

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

Number of Experts/Qualifications: Not applicable to this type of 510(k) summary for an immunoassay. The "ground truth" for an immunoassay like this would be established through analytical validation measures (e.g., comparison to a reference method, spiked samples, known concentrations) and clinical correlation, rather than expert consensus on diagnostic images or pathology.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of medical images or other subjective data is being evaluated, often in the context of establishing ground truth through expert consensus. For an immunoassay, the "ground truth" is determined by reference methods or defined concentrations, not expert adjudication.

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

MRMC Study: No. This is an immunoassay for measuring a hormone concentration, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant here.

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

Standalone Performance: For an immunoassay, the device itself provides the quantitative measurement. Its "standalone performance" refers to its analytical performance (accuracy, precision, linearity, etc.). While these studies were undoubtedly performed as part of the 510(k) submission to establish substantial equivalence, the specific details or results of these studies are not provided in this summary. The device operates automatically once the sample is loaded into the IMMULITE® Automated Analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For an immunoassay like IMMULITE® Turbo Intact PTH, the "ground truth" for analytical performance would typically be established by:
- Reference Methods: Comparison against established, well-characterized reference methods for PTH measurement.
- Certified Reference Materials/Standards: Use of materials with known, accurately assigned concentrations of intact PTH.
- Expected Physiological Ranges: Correlation with expected PTH levels in healthy and diseased populations clinically, often in comparison to results from a predicate device.
- Recovery Experiments: Adding known amounts of intact PTH to samples and measuring how accurately the device recovers the added amount.
  The specific methods used are not detailed in this summary.

8. The sample size for the training set

Sample Size (Training Set): Not applicable in the context of this device as described. This is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves calibration with known standards, rather than training a model on a large dataset. While developmental and optimization work would have involved many samples, they wouldn't be referred to as a "training set" in the AI/ML context.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth in that context). Calibration is performed using manufacturer-provided calibrators with assigned values based on reference methods and standardization procedures.

Summary

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K 992105

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510(k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name: Address:

Telephone Number: Facsimile Number:

Contact Person:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Edward M. Levine, Ph.D. Director of Clinical Affairs

IMMULITE® Turbo Intact PTH

(310) 645-8200

(310) 645-9999

June 21, 1999

LSKPTZ (50 tests)

EDTA plasma or serum.

5700 West 96th Street

Date of Preparation:

Device Name: Trade:

Catalog Number:

Common:

Classification:

Manufacturer:

Sole U.S. Importer:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Los Angeles, California 90045-5597

Diagnostic Products Corporation

Establishment Registration Number:

Description of Device:

DPC's Registration Number is 2017183

Class II device, 75-CEW (21CFR 862.1545)

IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer,

Reagent system for the determination of intact PTH in

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Intended Use of the Device:

IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or It is intended strictly for in vitro use as an aid in the differential diagnosis of serum. hypercalcemia and hypocalcemia.

Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Intact PTH.

Edward A. Levine, Ph.D.

Edward M. Levine, Ph.D. Director of Clinical Affairs

6/21/99
Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL -6 1999

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles. California 90045-5597

Re: K992105

Trade Name: IMMULITE® Turbo Intact PTH Regulatory Class: II Product Code: CEW Dated: June 21, 1999 Received: June 22, 1999

Dear Dr. Levine:

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 legally marketed predicate 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

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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 (770) 488-7655.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the @ffice of Compliance at ** (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Toutman

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): 449105 Device Name: IMMULITE® Turbo Intact PTH

Indications For Use:

Coofer

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992105

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

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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.