VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction.
VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.

Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB assay, and VITROS Immunodiagnostic Products High Sample Diluent B).
The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
Common reagents used by the VITROS System in each assay.
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

AI/ML Overview

The provided text describes a 510(k) summary for the VITROS CK-MB assay but it does not contain the specific details about acceptance criteria, detailed performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or MRMC studies that would allow for a complete response to all aspects of your request. It mainly focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract the information that is present:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and a "reported device performance" against those targets in the format requested. Instead, it describes characteristics of the new device and compares them to the predicate device to demonstrate substantial equivalence. The overall conclusion is that the performance is "substantially equivalent."

Device Characteristic	VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) (New Device)	VITROS CK-MB assay for use with human serum (Predicate Device)
Calibration range	0-400 ng/mL	0-400 ng/mL
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Enzyme labeled
Antibody	Mouse monoclonal anti-CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent).	Mouse monoclonal anti-CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent).
Instrumentation	VITROS Immunodiagnostic System	VITROS Immunodiagnostic System
Sample type	Serum and plasma (EDTA or heparin)	Serum
Sample volume	40μL	40μL
Incubation time and temperature	16 minutes at 37°C with shaking	16 minutes at 37°C with shaking

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

The document states: "Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories." However, it does not specify the sample size used for the test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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)

This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for measuring CK-MB. The "ground truth" for such devices is typically established through reference methods or quantitative chemical analysis, not by human expert interpretation of images or clinical data in the same way as, for example, a radiology AI device. Therefore, the concept of "experts used to establish ground truth" with their qualifications is not applicable in this context.

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

Not applicable for an in-vitro diagnostic immunoassay. The evaluation relies on quantitative measurements against reference standards, not on human adjudication of ambiguous cases.

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 is an immunoassay, not an AI or imaging device that assists human readers.

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

This refers to the performance of the immunoassay itself in producing quantitative measurements of CK-MB. The entire submission describes the standalone performance of this diagnostic assay. The device is intended for in vitro quantitative measurement and operates without a human-in-the-loop directly influencing the measurement result once the sample is processed.

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

For an immunoassay like the VITROS CK-MB assay, the "ground truth" is typically established by:

Reference methods: Highly accurate and precise analytical methods.
Known concentrations: Samples with precisely known concentrations of the analyte (CK-MB) through gravimetric preparation or using certified reference materials.
Clinical correlation: While not technically "ground truth" for the measurement itself, the clinical utility of the measurement (i.e., its correlation with myocardial infarction) is a broader context.

The document states that equivalence was demonstrated using "patient samples covering a variety of clinical categories," implying that the measurements from the new device were compared to those from the predicate device on these samples, with the predicate device's results serving as the de facto reference for demonstrating equivalence in clinical performance.

8. The sample size for the training set

This document describes a 510(k) submission for an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.

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

As explained above, the concept of a "training set" is not applicable for this type of device.

Summary

{0}------------------------------------------------

Summary Information

510(k) Summary

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.

The assigned 510(k) number is: K 993.068

1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041
  Marlene Shulman Contact Person:
Date Special 510(k) prepared: 10 September 1999 2. Preparation date
1. Device Trade or Proprietary Name: name VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators

: CK-MB assay Common Name Classification Name: Creatine phosphokinase/ creatine kinase or isoenzymes test system

1. Predicate The VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with device human serum and plasma (EDTA or heparin) and VITROS Immunodiagnostic Products CK-MB Calibrators are substantially equivalent to the VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with human serum and VITROS Immunodiagnostic Products CK-MB Calibrators.
  Continued on next page

{1}------------------------------------------------

510(k) Summary. Continued

5. Device The VITROS Immunodiagnostic System uses luminescence as the signal in description the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894).
1. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
1. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

Continued on next page

{2}------------------------------------------------

510(k) Summary, Continued

•

5.	Device description,Continued	The VITROS System and common reagents are dedicated specifically for useonly with the VITROS Immunodiagnostic Products range of immunoassayproducts.
6.	Device intended use	The VITROS CK-MB assay is intended for the in vitro quantitativemeasurement of CK-MB in human serum or plasma (EDTA or heparin).
7.	Comparison to predicate device	The VITROS Immunodiagnostic Products CK-MB Reagent Pack for usewith human serum and plasma (EDTA or heparin) and VITROSImmunodiagnostic Products CK-MB Calibrators are substantially equivalentto VITROS Immunodiagnostic Products CK-MB Reagent Pack for use withhuman serum which was cleared by the FDA (K973030) for IVD use.Table 1 lists the characteristics of the assays performed using the VITROSCK-MB assay for use with human serum and plasma (EDTA or heparin) andthe VITROS CK-MB assay for use with human serum.

Continued on next page

. .

{3}------------------------------------------------

510(k) Summary, Continued

1. Comparison Table 1 to predicate device, Continued

DeviceCharacteristic	VITROS CK-MB assayfor use with humanserum and plasma(EDTA or heparin)	VITROS CK-MB assayfor use with humanserum
Calibration range	0-400 ng/mL	0-400 ng/mL
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Enzyme labeled
Antibody	Mouse monoclonal anti-CK-BB antibody(Biotinylated antibodyreagent).Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent).	Mouse monoclonal anti-CK-BB antibody(Biotinylated antibodyreagent).Mouse monoclonal anti-CK-MB antibody (HRP-Conjugate reagent)
Instrumentation	VITROSImmunodiagnosticSystem	VITROSImmunodiagnosticSystem
Sample type	Serum and plasma(EDTA or heparin).	Serum
Sample volume	40μL	40μL
Incubation time andtemperature	16 minutes at 37°C withshaking	16 minutes at 37°C withshaking

Continued on next page

{4}------------------------------------------------

510(k) Summary, Continued

Conclusions The data presented in the pre-market notification demonstrate that the performance of the VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories.

The data presented in the premarket notification provide a reasonable assurance that the VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) is safe and effective for the stated intended use.

{5}------------------------------------------------

Image /page/5/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines that suggest a head, torso, and legs.

OCT 4 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101

K993068 Re:

Trade Name: VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators Regulatory Class: II Product Code: JHX, JIS Dated: September 10, 1999 Received: September 13, 1999

Dear Ms. Shulman:

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.

{6}------------------------------------------------

Page 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{7}------------------------------------------------

Statement of Intended Use

Page I of 1

510(k) Number (if known):	K 993068
Device Name:	VITROS Immunodiagnostic Products CK-MB Reagent PackVITROS Immunodiagnostic Products CK-MB Calibrators
Indications for Use:	VITROS CK-MB Reagent Pack - Creatinephosphokinase/creatine kinase or isoenzymes test systems is adevice intended to measure the enzyme creatine phosphokinaseor its isoenzymes in serum and plasma in the diagnosis andtreatment of myocardial infarction.
	VITROS CK-MB Calibrators - For in vitro use in the calibrationof the VITROS Immunodiagnostic System for the quantitativemeasurement of CK-MB in human serum and plasma.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993068

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Ortho-Clinical Diagnostics

VITROS Immunodiagnostic Products CK-MB Reagent Pack -VITROS Immunodiagnostic Products CK-MB Calibrators

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.