MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or bodily fluids. Preservatives and stabilizers are added to maintain product integrity.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called MAS® PTH Control and Moni-Trol® PTH Control. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The device is a quality control material for monitoring assay conditions for Parathyroid hormone (PTH) determinations. Its primary function is to assure consistent performance of reagents and instruments, not to directly diagnose or screen patients. Therefore, the types of acceptance criteria and studies typically associated with diagnostic algorithms (e.g., sensitivity, specificity, clinical outcome studies, multi-reader multi-case studies) are not applicable or described for this type of device.

Here's a breakdown of why the requested information isn't present in the provided text:

Acceptance criteria and reported device performance: These are not detailed in the context of clinical accuracy metrics, as the device is a control material. The "Comparison of Technological Characteristics" table presents differences in intended use, description, matrix, form, storage conditions, stability, and analytes compared to the predicate device. For a control, performance is typically assessed by its stability, consistency, and ability to provide expected values when tested with various assay systems, allowing laboratories to monitor the performance of those assays. These types of performance characteristics are generally verified internally by the manufacturer through analytical studies (e.g., precision, accuracy, linearity) but are not explicitly presented as "acceptance criteria" against which a device's clinical performance is measured in this summary.
Sample size for the test set and data provenance: Not applicable. There is no "test set" in the sense of patient data used to evaluate a diagnostic algorithm. Performance would be assessed through internal analytical testing of the control material itself (e.g., stability studies, homogeneity studies), not a clinical test set.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for a control material would be its assigned value, determined by the manufacturer based on target analytes and reference methods, not by expert consensus on clinical cases.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks. This device is a quality control.
Standalone performance study: Not applicable in the sense of an algorithm's diagnostic performance. The "performance" of this device relates to its ability to serve as a reliable control.
Type of ground truth used: For a quality control material, the "ground truth" is the established reference value for the analyte within the control, which is determined by the manufacturer using validated methods.
Sample size for the training set: Not applicable. This is not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on the regulatory aspects of introducing a new quality control material, primarily demonstrating its substantial equivalence to an existing predicate device based on its intended use, technological characteristics, and performance as a control. It does not contain the information requested regarding acceptance criteria and clinical study results that would be relevant for a diagnostic or screening device.

Summary

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510K SUMMARY

DEC = 3 ""09

109274

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92

The assigned 510(k) number is: TBD

COMPANY/CONTACT PERSON

Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific, Specialty Diagnostics Division, CDx Fremont 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 office (510) 979-5422 fax

DATE PREPARED

August 30, 2009

DEVICE NAME

Trade Names:

MAS® PTH Control Moni-Trol® PTH Control

Common Names:

Liquid Assayed PTH Control

Device Classification: Class I

Classification Panel: Quality Control Material (Assayed and Unassayed) for Clinical Chemistry

Regulation number: 21 CFR 862.1660

Product Code: JJX

INTENDED USE:

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SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE

MAS® PTH Control Moni-Trol® PTH Control is substantially equivalent to the previously cleared Liquichek ™ Specialty Immunoassay Control (K043108)

DESCRIPTION OF DEVICE

Comparison	Predicate Device, K043108	Proposed new device
Intended Use	For use as quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.	MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations.
	Include PTH Control with patient serumspecimens when assaying forParathyroid hormones. Assay valuesare provided for the specific systemslisted. The user can compareobservations with expected ranges asmeans of assuring consistentperformance of reagent and instrument.
Descriptionof device	This product isprepared from humanserum with addedconstituents,chemicals, stabilizers,and preservatives.	This product is a liquid stable controlmaterial prepared from human serum.Analyte levels are adjusted with variouspure chemicals and preparations fromhuman tissue or bodily fluids.Preservatives and stabilizers are addedto maintain product integrity.
Matrix	Human Serum	Human Serum
Form	Liquid	Liquid
StorageCondition	-20°C to -70°C untilexpiration date on thelabel	-25°C to -15°C until expiration date onthe label
Open VialStability	30 days at 2-8°C withexceptions	30 days when stored tightly capped at2-8°C
Closed VialStability	30 days at 2-8°C withexceptions	90 days when stored tightly capped at2-8°C
Analytes	Anti-TgAnti-TPOC-PeptideErythroproteinIntact PTHIGF-IOsteocalcin25 OH Vitamin D	PTH

Comparison of Technological Characteristics

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and the comments of the comments of

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

DEC 3 2009

Microgenics Corporation c/o Ms. Lisa Charter Manager, Regulatory affairs Thermo Fisher Scientific Specialty Diagnostics Division, CDx Fremont 4630 Fremont Blvd. Fremont, CA 94538

Re: K092749

Trade/Device Name: MAS® PTH Control and Moni-Trol® PTH Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 04, 2009 Received: September 08, 2009

Dear Ms. Charter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);

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Page 2 - Ms. Lisa Charter

labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K092749

Device Name:

MAS® PTH Control Moni-Trol® PTH Control

Indication For Use:

MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Prescription Use x (21 CFR Part 801 Subpart D) Subpart C)

And/Or

Over the Counter Use (21 CFR Part 801

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Maria M. Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092749

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.