The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of myoglobin values.

Device Description

The Stratus® CS MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.

AI/ML Overview

The provided text describes a calibrator (Stratus® CS MYO CalPak) for an in vitro diagnostic device, not an AI/ML-driven medical device that analyzes data or images. As such, most of the questions regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of product.

The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device. The basis for acceptance is typically analytical performance, consistency, and stability of the calibrator itself, and its ability to properly calibrate the associated assay.

Here's an attempt to address the relevant points based on the provided text, and noting the inapplicable nature of others:

Device Name: Stratus® CS MYO CalPak

Device Type: In vitro diagnostic product (Calibrator for myoglobin method on Stratus® CS STAT fluorometric analyzer)

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

The provided text only states that the Stratus® CS MYO CalPak is "substantially equivalent to the Stratus® myoglobin calibrator as they are both intended to be used as calibrators for similar myoglobin methods." It does not provide specific acceptance criteria or performance data (e.g., precision, accuracy, linearity, stability) for the calibrator itself or the myoglobin assay when using this calibrator, which would typically be part of a full 510(k) submission.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text.	Substantially equivalent to the Stratus® myoglobin calibrator.

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

Not Applicable. This is a calibrator, not a diagnostic test for patient samples. Testing would involve analytical studies of the calibrator's properties and its effect on the assay, rather than evaluation with a "test set" of patient samples in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth for patient data is not established for a calibrator. The "ground truth" for a calibrator would relate to its manufacturing specifications and the known concentration of its analyte(s).

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

Not Applicable. Adjudication methods are used for interpreting clinical data, which is not the focus of this calibrator 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

Not Applicable. This device is a calibrator, not an AI/ML diagnostic aid for human readers.

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

Not Applicable. This device is a calibrator; it does not have an algorithm or standalone performance in the context of AI/ML.

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

For a calibrator, the "ground truth" typically refers to the certified or assigned value of the analyte (myoglobin in this case) within the calibrator material, established through precise analytical methods and often traceable to higher-order reference materials. The text states the CalPak has myoglobin at an approximate concentration of 850 ng/mL, implying this is its intended "ground truth" value for calibration.

8. The sample size for the training set

Not Applicable. This is a calibrator, not an AI/ML model that requires a training set.

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

Not Applicable. As above, no training set for an AI/ML model.

Summary

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1981101 DADE BEHRING

APR 1 5 1998

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

Stratus® CS MYO CalPak

Summary of Safety and Effectiveness

The Stratus® CS MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer.

The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.

The MYO CalPak is substantially equivalent to the Stratus® myoglobin calibrator as they are both intended to be used as calibrators for similar myoglobin methods.

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 25, 1998

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 5 1998

Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K981101 Stratus® CS MYO CalPak Regulatory Class: II Product Code: JIT Dated: March 25, 1998 Received: March 26, 1998

Dear Ms. George:

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 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 regulation 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 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 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 Bitman

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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Indications Statement

Device Name: Stratus® CS MYO CallPak

Indications for Use: The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of myoglobin values.

Carolyn K. George
Carolyn K. George

Regulatory Affairs and Compliance Manager

March 25, 1998
Date

Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 98/1101

510(k) Number

Division Sign-Off

Office of Device Evaluation

prescription use

0000000

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.