TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY by HYBRITECH, INC.

The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

Device Description

Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.

AI/ML Overview

The provided text describes the Tandem-MP Ostase Assay, an in vitro device for measuring skeletal alkaline phosphatase (sALP). However, it is a 510(k) premarket notification and focuses on demonstrating substantial equivalence to a predicate device (Tandem-R Ostase Immunoradiometric Assay, K961573) rather than a study providing acceptance criteria and performance data in the typical sense of a new device validation.

Therefore, many of your requested points cannot be directly extracted from this document, as it's not a performance study report for a novel AI device. This document is a regulatory filing for a laboratory assay.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting new, specific acceptance criteria and performance metrics for the new device in isolation. The document states that the Tandem-MP Ostase Assay "is substantially equivalent" to the predicate, implying its performance should be comparable.

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

This information is not provided. The text mentions "human serum" as the specimen matrix, but no details about sample size, origin, or study design (retrospective/prospective) are given.

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

This information is not provided. This concept (experts establishing ground truth) is more relevant for diagnostic imaging AI studies or studies where subjective interpretation is foundational. For an in vitro diagnostic assay, "ground truth" would typically refer to a gold standard measurement or clinically established normal/abnormal ranges, not expert consensus interpretation.

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

This information is not provided. Adjudication methods are typically used in studies where multiple human readers are evaluating data, often for diagnostic imaging, and is not relevant to this type of in vitro diagnostic assay submission.

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

This information is not provided. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging system that would involve human readers. Therefore, an MRMC study is not applicable here.

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

This information is not explicitly detailed in the way it would be for an AI algorithm. The Tandem-MP Ostase Assay is an immunoenzymetric assay, which is a laboratory test. Its performance is inherent in its chemical and biological reactions and subsequent colorimetric measurement, not in an "algorithm" in the AI sense. The entire assay itself is "standalone" in that it produces a quantitative result from a serum sample without human interpretive assistance for the result itself.

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

For an in vitro diagnostic assay like this, "ground truth" would typically refer to:

Reference Method/Predicate Device Comparison: The text implies comparison to the predicate device (Tandem-R Ostase Immunoradiometric Assay) is the basis for demonstrating equivalence in performance. This predicate device would serve as a de-facto "ground truth" for showing the new device measures the same analyte accurately.
Clinical Correlation: The device is used as an aid in managing postmenopausal osteoporosis and Paget's disease. The ultimate "ground truth" for clinical utility would be disease progression, response to treatment, or bone mineral density measurements, but the device itself directly measures sALP, which is an indicator of osteoblastic activity. The document doesn't detail how the correlation with clinical outcomes was established for this specific device (Tandem-MP Ostase), but it relies on the predicate's established clinical utility.

Specific details about how "ground truth" was established for testing the new device are not explicitly provided beyond the substantial equivalence claim.

8. The sample size for the training set

This information is not provided. As an in vitro diagnostic assay, it doesn't typically have a "training set" in the machine learning sense. The development and optimization of such assays involve reagent formulation, antibody selection, and protocol refinement, which are different from supervised learning with a data set.

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

This information is not applicable as there is no "training set" in the AI/machine learning sense for this type of device.

Summary

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SUMMARY OF SAFETY AND EFFECT SECTION X: THE TANDEM-MP OSTASE ASSAY

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This premarket notification has demonstrated that the Tandem-MP Ostase Immunoenzymetric Assay for the quantitative measurement of skeletal alkaline phosphatase to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease is substantially equivalent to the Tandem-R Ostase Immunoradiometric Assay that was cleared by FDA in a previous submission (#K961573).

The Safe Medical Devices Act of 1990 states that a device is substantially equivalent to its predicate if they have the same technological characteristics and the same intended use. The Tandem-MP Ostase device that is the subject of this submission has technological characteristics that are the same as those of the predicate device.

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The intended use of Tandem-MP Ostase remains unchanged from the predicate with regard to the analyte being measured (skeletal alkaline phosphatase) and the specimen matrix (human serum). Therefore, it has been demonstrated in this submission that the Tandem-MP Ostase assay is substantially equivalent to the predicate device and is safe and effective as an aid in the management of postmenopausal osteoporosis and Paget's disease.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other to create a sense of depth and unity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 1 1997

Gregory P. Payne, RAC Principal Regulatory Specialist Hybritech, Inc. 8958 Terman Court 92121 San Diego, California

K972666 Re : Tandem-MP Ostase™ Immunoenzymetric Assay Requlatory Class: II Product Code: CIN Dated: July 16, 1997 July 16, 1997 Received:

Dear Mr. Payne:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਸੇ 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CDIA-66), Child device may require does, you should contact Categorization: - 10 accemention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as Inis lector will and the premarket notification. The FDA described in your sister privalence of your device to a legally Finding or subbeancear equire in a classification for your marketed predicate device rour 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 Office 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/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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SECTION 11: INDICATION FOR USE

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4972666

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Prescription Use

Tandem-MP Ostase 510(k): July 16, 1997

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.