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.

Device Description

The VITROS Immunodiagnostic Products CK-MB assay is performed using the VITROS CK-MB Reagent Pack and the VITROS CK-MB Calibrators on the VITROS Systems.

The current VITROS Immunodiagnostic Products CK-MB assay is susceptible to interference from biotin. Ortho has made a modification to the manufacturing process to allow the biotinylated antibody capture conjugate to be pre-bound to the well, thus mitigating the risk of biotin interference.
The modified product utilizes all the same antibodies and raw materials with the exception of the addition of 0.7% Tween 20 and an increase in EDTA concentration from 0.001M to 0.030M, both of these modifications are to improve serum/plasma agreement which required a conversion factor in the previously cleared product.

An immunometric immunoassay technique is used, which involves the reaction of CK-MB present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-CK-BB bound to Streptavidin), and a Horseradish Peroxidase (HRP)-labeled antibody conjugate (Mouse monoclonal anti-CK-MB). Unbound (HRP)-labeled anti-CK-MB antibody conjugate is removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of CK-MB conjugate bound is directly proportional to the concentration of CK-MB present in the sample.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the VITROS Immunodiagnostic Products CK-MB Reagent Pack. This is an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts for ground truth, adjudication methods, MRMC studies, sample sizes for training sets) are not applicable to this document.

The document focuses on demonstrating the substantial equivalence of a modified CK-MB assay to a legally marketed predicate device, primarily through non-clinical performance studies.

Here's an analysis based on the provided text, addressing the applicable criteria for an in vitro diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this, acceptance criteria typically revolve around analytical performance characteristics such as precision, linearity, detection limits, and method comparison to a predicate. The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents the results of various validation studies.

Performance Characteristic	Acceptance Criteria (Implied/Standard)	Reported Device Performance (VITROS CK-MB Reagent Pack)
Precision	Repeatability & Within-Lab CV% within acceptable ranges for diagnostic assays.	Repeatability: 1.8 ng/mL: 2.7% CV 16.90 ng/mL: 2.4% CV 46.3 ng/mL: 1.7% CV 256 ng/mL: 1.7% CV Within Lab: 1.8 ng/mL: 7.1% CV 16.90 ng/mL: 5.0% CV 46.3 ng/mL: 5.5% CV 256 ng/mL: 5.0% CV
Limit of Detection (LoD)	LoD clinically sensitive enough for intended use.	LoD: 0.22 ng/mL (µg/L)
Limit of Quantitation (LoQ)	LoQ clinically relevant for intended use.	LoQ: 0.22 ng/mL (µg/L)
Limit of Blank (LoB)	LoB sufficiently low to detect absent analyte.	LoB: 0.07 ng/mL (µg/L)
Linearity/Measuring Range	Range should cover clinically relevant concentrations.	Measuring Range: 0.22–400 ng/mL (µg/L)
Analytical Specificity (Interferences)	Bias from common interferents should be minimal (<10% typically, or noted if higher).	Interferents with >10% bias noted: - Cefoxitin (at 521 mg/dL): -27.7% bias at 3.00 ng/mL CK-MB - Dextran 40 (at 2400 mg/dL): -15.0% bias at 3.00 ng/mL CK-MB; -44.9% bias at 50.0 ng/mL CK-MB
Cross-Reactivity	Minimal or no cross-reactivity with structurally similar substances.	CK-BB (50 µg/dL): Not Detectable CK-MM (4 mg/dL): Not Detectable
Method Comparison to Predicate Device (Accuracy)	Strong correlation and minimal bias compared to the predicate device, with slope close to 1 and intercept close to 0.	System (3600 vs. Comparative Method): - n: 149 patient samples - Slope: 0.99 (95% CI: 0.9812 to 0.9950) - Correlation Coefficient: 0.999 - Intercept: 0.112 ng/mL (95% CI: 0.05080 to 0.1723)
High Dose Hook Effect	No significant hook effect within relevant supraphysiological concentrations.	No high dose hook effect up to 44,200 ng/mL (µg/L).

2. Sample Sizes Used for the Test Set and Data Provenance

Precision:
- Sample Size: 80 observations (likely meaning replicates across runs and days, as per CLSI EP05 methodology) for each of 4 patient pools.
- Data Provenance: Not explicitly stated, but typically from internal lab testing.
Limit of Detection/Quantitation: Not explicitly stated, but derived from experiments consistent with CLSI document EP17.
Analytical Specificity (Interference) & Cross-Reactivity: Not explicitly stated, but involves testing at specific concentrations of CK-MB and interferents.
Method Comparison to Predicate Device:
- Sample Size: 149 patient (serum) samples.
- Data Provenance: Not explicitly stated regarding country of origin, but described as "patient (serum) samples," implying collected clinical samples. The study is an analytical/non-clinical study, not a clinical trial, so it's prospective in the sense of testing the new device on these samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is an in vitro diagnostic device measuring a biomarker concentration. The "ground truth" for method comparison is the measurement obtained by the predicate device and the analytical properties of the reference materials. Expertise is in laboratory medicine and analytical chemistry, not interpretation of images for diagnosis by human experts.

4. Adjudication Method for the Test Set

Not Applicable. As above, no human expert adjudication is involved in establishing the "ground truth" for quantitative assay validation.

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 not an AI/ML device, nor does it involve human readers interpreting images.

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

Not Applicable. While the device operates standalone (human performs the test, the system provides a result), the concept of an "algorithm only" performance study typically refers to AI/ML models. For an IVD, the "standalone performance" is exactly what is described in the precision, linearity, and detection limit sections.

7. The Type of Ground Truth Used

For precision, linearity, and detection limits: Analyte concentrations of reference materials or patient pools. The "truth" is established by highly controlled laboratory methods.
For method comparison: Results obtained from the legally marketed predicate device (VITROS Immunodiagnostic CK-MB Reagent Pack, K993068). The predicate serves as the "true" or gold standard against which the modified device is compared. This is a common "ground truth" for demonstrating substantial equivalence for IVDs. While not explicitly stated, these predicate measurements would have been established through a similar robust validation process.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set" in the sense of machine learning. The device's performance characteristics are inherent to its chemical and biological components and manufacturing process, validated through the non-clinical studies detailed.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The device development involved standard IVD R&D and manufacturing, not machine learning training.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

January 28, 2022

Ortho Clinical Diagnostics Declan Hynes Regulatory Affairs Manager Felindre Meadows Pencoed, Bridgend CF35 5PZ United Kingdom

Re: K212648

Trade/Device Name: VITROS Immunodiagnostic Products CK-MB Reagent Pack Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase Or Isoenzymes Test System Regulatory Class: Class II Product Code: JHX Dated: September 23, 2021 Received: September 28, 2021

Dear Declan Hynes:

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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K212648

Device Name

VITROS Immunodiagnostic Products CK-MB Reagent Pack

Indications for Use (Describe) Rx ONLY

For in vitro diagnostic use only.

For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System.

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

This summary of 510(k) safety and effectivenessinformation is being submitted in accordance with therequirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K212648
1. Submittername,address,contact	Ortho Clinical DiagnosticsFelindre Meadows, Pencoed, Bridgend CF35 5PZ GBR+44 (656) 778-032Contact Person: Declan Hynes, Regulatory AffairsManager
2. PreparationDate	January 27th, 2022
3. Devicename	Trade or Proprietary Names:VITROS Immunodiagnostic Products CK-MB Reagent PackCommon Name: VITROS CK-MBAssay Classification: 862.1215 Creatine phosphokinase/creatinekinase or isoenzymes test system.Product Code: JHX
4. PredicateDevice	VITROS Immunodiagnostic Products CK-MB Reagent Pack, K993068
5. Devicedescription	The VITROS Immunodiagnostic Products CK-MB assay is performedusing the VITROS CK-MB Reagent Pack and the VITROS CK-MBCalibrators on the VITROS Systems.The current VITROS Immunodiagnostic Products CK-MB assay issusceptible to interference from biotin. Ortho has made a modificationto the manufacturing process to allow the biotinylated antibody captureconjugate to be pre-bound to the well, thus mitigating the risk of biotininterference.The modified product utilizes all the same antibodies and raw materialswith the exception of the addition of 0.7% Tween 20 and an increase inEDTA concentration from 0.001M to 0.030M, both of thesemodifications are to improve serum/plasma agreement which required aconversion factor in the previously cleared product.

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

Modified Assay Architecture

Image /page/4/Figure/1 description: The image shows a diagram of a Streptavidin/Biotinylated anti-CK-BB coated well. The diagram shows the well coated with biotinylated mouse monoclonal anti-CK-BB, which binds to CK-MB. HRP-labeled mouse monoclonal anti-CK-MB then binds to the CK-MB, and a signal reagent with enhancer is added, resulting in luminescence.

1. Device Rx ONLY intended For in vitro diagnostic use only. use For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System. 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.

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

1. Compari-The following tables provide a summary of the key features of the new son to device assessed against the predicate. predicate device:

DeviceCharacteristic	Predicate DeviceVITROS ImmunodiagnosticProducts CK-MB Reagent Pack,K993068, cleared 4 October 1999	Modified DeviceVITROS ImmunodiagnosticProducts CK-MB Reagent Pack
Intended Use	Rx ONLYFor in vitro diagnostic use only.For the quantitative measurementof CK-MB in human serum andplasma (EDTA or heparin)	Same
Basic Principle	Sandwich immunoassay	Same
Antibody	Monoclonal anti-CK-MB andanti-CK-BB	Same
Sample Type	Serum and plasma	Same
Traceability	Calibrated against a commerciallyavailable CK-MB assay	Same
MeasuringRange	0.22-400 ng/mL (µg/L)	0.22-400 ng/mL (µg/L)
Detection Limit	LOB: 0.07 ng/mLLOD: 0.22 ng/mL	LOB: 0.07 ng/mLLOD: 0.22 ng/mLLOQ: 0.22 ng/mL
ReagentStability	Unopened:Up to expiration date stored at 2-8°COpened:8 weeks on VITROS System	Unopened:Up to expiration date stored at 2-8°COpened:8 weeks on VITROS System

Nonclinical performance

Several nonclinical tests were performed. See Instruction for Use claims below:

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

Precision

Precision was evaluated with patient pool on the systems in the table below following the CLSI document EP05.

	Conventional & SI Units (ng/mL)
System	MeanActivity	Repeatability		Within Lab		No. ofObs.	No. of Days
		SD	CV%	SD	CV%
3600	1.8	0.049	2.7%	0.129	7.1%	80	20
	16.90	0.397	2.4%	0.843	5.0%	80	20
	46.3	0.793	1.7%	2.529	5.5%	80	20
	256	4.238	1.7%	12.694	5.0%	80	20

*Repeatability (formerly called within-run precision) was determined using two replicates per run.

**Within Lab precision was determined using a single reagent lot and a single calibration.

Limit of Detection

The Limit of Detection (LoD) for the VITROS Immunodiagnostic CK-MB Reagent Pack is 0.07 mIU/mL (IU/L), determined consistent with CLSI document EP17. The Limit of Quantitation (LoQ) was determined consistent with CLSI document EP17.

LoB ng/mL (µg/L)	LoD ng/mL (µg/L)	LoQ ng/mL (µg/L)
0.07	0.22	0.22

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

Linearity/Measuring Range

VITROS System	Measuring (Reportable) Range
3600	0.22–400 ng/mL (µg/L)

Matrix Comparison

Specimens Recommended

Serum
Plasma (Lithium Heparin)
Plasma (K2 EDTA)

Specimens Not Recommended

Do not use turbid specimens. Turbidity in specimens may affect test results.

Analytical Specificity

Known Interferences

The VITROS Immunodiagnostic CK-MB Reagent Pack was screened for interfering substances at CK-MB concentrations of approximately 3.00 ng/mL (ug/L) and 50.0 ng/mL (ug/L) following CLSI EP07 and EP37. The substances listed in the table demonstrated observed bias of > 10% when tested at the concentrations shown.

	Conventional Units		Alternate Units
Interferent	CK-MB Conc.(ng/mL)	InterferentConcentration	CK-MB Conc.(\u00b5g/L)	InterferentConcentration	% Bias
Cefoxitin	3.00	521 mg/dL	3.00	11.6 mmol/L	-27.7
Cefoxitin	3.00	348 ng/dL	3.00	7.75 mmol/L	-8.1
Dextran 40	3.00	2400 mg/dL	3.00	600 \u00b5mol/L	-15.0
Dextran 40	3.00	1800 mg/dL	3.00	450 \u00b5mol/L	-8.9
Dextran 40	50.0	2400 mg/dL	50.0	600 \u00b5mol/L	-44.9
Dextran 40	50.0	1800 mg/dL	50.0	450 \u00b5mol/L	9.0

Other Limitations

The results from this or any other diagnostic test should be used and interpreted only in the context of the overall clinical picture.

The VITROS Immunodiagnostic CK-MB Reagent Pack has no high dose hook effect up to 44,200 ng/mL (µg/L).

{8}------------------------------------------------

Elevated CK-MB concentrations have been observed in patients experiencing skeletal muscle trauma, renal failure and certain chronic heart pathologies, as well as after strenuous exercise. Factors that may aid in the diagnosis of myocardial infarction include the pattern of rise and fall in CK-MB concentrations as well as the ratio of CK-MB concentration to total CK activity. These and other appropriate clinical factors should be considered when interpreting test results.

Heterophilic antibodies in the serum or plasma samples may cause interference in immunoassays. These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products. Results that are inconsistent with clinical observations indicate the need for additional testing.

Certain drugs and clinical conditions are known to alter CK-MB concentrations in vivo. For additional information, refer to one of the published summaries referenced in the product Instruction for Use.

Specificity

Substances that Do Not Interfere

The substances listed in the table below were tested with the VITROS Immunodiagnostic CK-MB Reagent Pack following CLSI EP07 and EP37 and found not to cause bias > 10% at CK-MB concentrations of approximately 3.00 ng/mL (ug/L) and 50.0 ng/mL (ug/ L) at the test concentrations shown.

Substance	Concentration	Concentration
Acetaminophen	15.6 mg/dL	1032 µmol/L
N-Acetylcysteine	15 mg/dL	920 µmol/L
Amoxicillin	5.40 mg/dL	148 µmol/L
Ascorbic acid	5.25 mg/dL	298 µmol/L
Bilirubin, conjugated	40 mg/dL	475 µmol/L
Bilirubin, unconjugated	40 mg/dL	475 µmol/L
Biotin	3510 ng/mL	14.3 µmol/L
Carbamazepine	4.50 mg/dL	191 µmol/L
Carvedilol	5 mg/dL	123 µmol/L
Captopril	0.264 mg/dL	12.2 µmol/L
Cholesterol	400 mg/dL	10.3 mmol/L
Clopidogrel	30 mg/dL	932 µmol/L
Codeine	0.141 mg/dL	5 µmol/L
Cotinine	0.24 mg/dL	13.6 µmol/L
Dextromethorphan	0.00156 mg/dL	0.042 µmol/L
Digoxin	0.0039 mg/dL	0.050 µmol/L
Substance	Concentration
Enoxaparin (Low Molecular WeightHeparin)	360 U/dLN/A
Ethanol	600 mg/dL130 mmol/L
Furosemide	1.59 mg/dL48 µmol/L
Hemoglobin	1000 mg/dL155 µmol/L
Heparin (sodium)	330 U/dLN/A
Hydralazine hydrochloride	1.44 mg/dL73.2 µmol/L
Hydrocodone	0.0072 mg/dL0.2 µmol/L
Ibuprofen	71 mg/dL3.45 mmol/L
Levothyroxine	0.0429 mg/dL0.552 µmol/L
Loratadine	0.0087 mg/dL0.227 µmol/L
Naproxen	36 mg/dL1.43 mmol/L
Nifedipine	0.0588 mg/dL1.7 µmol/L
Oleic acid	40 mg/dL0.142 µmol/L
Omeprazole	0.840 mg/dL24.3 µmol/L
Phenytoin	6.00 mg/dL238 µmol/L
Prednisone	0.010 mg/dL0.280 µmol/L
Propranolol HCl	0.115 mg/dL3.89 µmol/L
Rheumatoid factor	900 IU/mLN/A
Rivaroxaban	0.270 mg/dL6.19 µmol/L
Salicylic acid	2.86 mg/dL207 mmol/L
Streptokinase	150,000 U/dLN/A
Theophylline	6.0 mg/dL333 µmol/L
Total protein	15 g/dL17.1 nmol/L
Tissue Plasminogen Activator(TPA)	1.2 mg/dLN/A
Triglycerides	1500 mg/dL16.9 mmol/L
Triolein	3000 mg/dL3.31 µmol/L
Vancomycin hydrochloride	12.3 mg/dL8.28 mmol/L
Verapamil	0.160 mg/dL3.52 µmol/L
Warfarin sodium	8.0 mg/dL242 µmol/L

{9}------------------------------------------------

{10}------------------------------------------------

Cross-Reactivity

The cross-reactivity of the VITROS Immunodiagnostic CK-MB Reagent Pack was evaluated by adding the following substances to a sample containing no CK-MB.

Test Substance	Concentration	% Cross-reactivity
CK-BB	50 µg/dL	ND*
CK-MM	4 mg/dL	ND*

*Not Detectable. Concentration was below the measuring interval of the test, 0.22 to 400 ng/mL (ug/L).

Dilution

CK-MB samples with concentrations greater than the measuring range may be automatically diluted on the system 5- fold (1 part sample with 4 parts diluent) by the VITROS Immunodiagnostic System with the VITROS High Sample Diluent B Reagent Pack prior to test. Refer to the VITROS High Sample Diluent B Reagent Pack instructions for use.

High Dose Hook

The VITROS Immunodiagnostic CK-MB Reagent Pack has no high dose hook effect up to 44,200 ng/mL (ug/L).

Sample Stability

Same as K993068

Expected Values

Same as K993068

Traceability of Calibration

Same as K993068

{11}------------------------------------------------

Method Comparison to Predicate Device

Accuracy was evaluated consistent with CLSI document EP09. The plot and table show the results of a method comparison study using patient (serum) samples analyzed on the VITROS 3600 Immunodiagnostic System using the candidate VITROS CK-MB Reagent Pack compared with those analyzed using the cleared predicate VITROS Immunodiagnostic CK-MB Reagent Pack. The relationship between the 2 methods was determined by Weighted Deming regression.

Image /page/11/Figure/2 description: The image shows a scatter plot titled "Conventional units". The y-axis is labeled "VITROS CK-MB (1300A) ng/mL" and ranges from 150 to 400. The data points are clustered along a diagonal, with some points falling outside the dashed lines. A red line is present near the bottom of the plot, close to the 180 mark.

System	n	Slope	CorrelationCoefficient	Conventional Units(ng/mL)		Alternate Units(µg/L)
				Range ofSampleActivity	Intercept	Range ofSampleActivity	Intercept
3600 vs.ComparativeMethod	149	0.99	0.999	0.61-378	0.112	0.61-378	0.112

Parameter	95% CI
Intercept	0.05080 to 0.1723
Slope	0.9812 to 0.9950

{12}------------------------------------------------

9. Clinical performance

N/A

10. Conclusions

The submitted information in this premarket notification supports a substantial equivalence decision.

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.