(158 days)
Not Found
No
The device description and performance studies focus on a standard immunometric immunoassay technique and analytical performance metrics, with no mention of AI or ML algorithms.
No.
Explanation: The device is described as "For in vitro diagnostic use only" and its intended use is for the "quantitative measurement of CK-MB in human serum and plasma." This indicates it is used to diagnose or monitor conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and "Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases".
No
The device description clearly outlines a reagent pack and calibrators used with a specific hardware system (VITROS 3600 Immunodiagnostic System) to perform an immunoassay. This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document clearly states "For in vitro diagnostic use only." in the "Intended Use / Indications for Use" section.
- Purpose: The device is intended for the "quantitative measurement of CK-MB in human serum and plasma," which are biological samples taken from the body.
- Clinical Application: The measurements are used "in the diagnosis and treatment of myocardial infarction and muscle diseases," indicating a clinical diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay technique performed on a specific system (VITROS 3600 Immunodiagnostic System) using reagents and calibrators, which is characteristic of IVD devices.
- Performance Studies: The document describes various performance studies (Precision, Limit of Detection, Linearity, Analytical Specificity, Method Comparison, etc.) that are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K993068) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, comparing it to a previously cleared IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance studies were performed including Precision, Limit of Detection, Linearity/Measuring Range, Matrix Comparison, Analytical Specificity (Known Interferences and Substances that Do Not Interfere), Cross-Reactivity, Dilution, High Dose Hook, Sample Stability, Expected Values, and Traceability of Calibration.
Precision was evaluated with patient pool on the systems following CLSI document EP05. For System 3600, mean activities of 1.8, 16.90, 46.3, and 256 showed repeatability CV% of 2.7%, 2.4%, 1.7%, and 1.7% respectively, and Within Lab CV% of 7.1%, 5.0%, 5.5%, and 5.0% respectively.
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. LoB, LoD, and LoQ are 0.07, 0.22, and 0.22 ng/mL (ug/L) respectively.
The Measuring (Reportable) Range for VITROS System 3600 is 0.22–400 ng/mL (ug/L).
Method Comparison to Predicate Device: Accuracy was evaluated consistent with CLSI document EP09. A method comparison study using 149 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. The slope was 0.99 with a Correlation Coefficient of 0.999. The intercept was 0.112. The 95% CI for the intercept was 0.05080 to 0.1723 and for the slope was 0.9812 to 0.9950.
Clinical performance: N/A.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOB: 0.07 ng/mL
LOD: 0.22 ng/mL
LOQ: 0.22 ng/mL
Measuring Range: 0.22-400 ng/mL (ug/L)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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3
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: K212648 | |
| 1. Submitter | |
| name, | |
| address, | |
| contact | Ortho Clinical Diagnostics |
| Felindre Meadows, Pencoed, Bridgend CF35 5PZ GBR | |
| +44 (656) 778-032 | |
| Contact Person: Declan Hynes, Regulatory Affairs | |
| Manager | |
| 2. Preparation | |
| Date | January 27th, 2022 |
| 3. Device | |
| name | Trade or Proprietary Names: |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack | |
| Common Name: VITROS CK-MB | |
| Assay Classification: 862.1215 Creatine phosphokinase/creatine | |
| kinase or isoenzymes test system. | |
| Product Code: JHX | |
| 4. Predicate | |
| Device | VITROS Immunodiagnostic Products CK-MB Reagent Pack, K993068 |
| 5. 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. |
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.
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.
-
- 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.
- 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
5
-
- Compari-The following tables provide a summary of the key features of the new son to device assessed against the predicate. predicate device:
| Device
Characteristic | Predicate Device
VITROS Immunodiagnostic
Products CK-MB Reagent Pack,
K993068, cleared 4 October 1999 | Modified Device
VITROS Immunodiagnostic
Products CK-MB Reagent Pack |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Rx ONLY
For in vitro diagnostic use only.
For the quantitative measurement
of CK-MB in human serum and
plasma (EDTA or heparin) | Same |
| Basic Principle | Sandwich immunoassay | Same |
| Antibody | Monoclonal anti-CK-MB and
anti-CK-BB | Same |
| Sample Type | Serum and plasma | Same |
| Traceability | Calibrated against a commercially
available CK-MB assay | Same |
| Measuring
Range | 0.22-400 ng/mL (µg/L) | 0.22-400 ng/mL (µg/L) |
| Detection Limit | LOB: 0.07 ng/mL
LOD: 0.22 ng/mL | LOB: 0.07 ng/mL
LOD: 0.22 ng/mL
LOQ: 0.22 ng/mL |
| Reagent
Stability | Unopened:
Up to expiration date stored at 2-
8°C
Opened:
8 weeks on VITROS System | Unopened:
Up to expiration date stored at 2-
8°C
Opened:
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 | Mean | ||||||
| Activity | Repeatability | Within Lab | No. of | ||||
| Obs. | 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) | Interferent | ||||
| Concentration | CK-MB Conc. | ||||
| (\u00b5g/L) | Interferent | ||||
| Concentration | % 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 Weight | ||
| Heparin) | 360 U/dL | |
| N/A | ||
| Ethanol | 600 mg/dL | |
| 130 mmol/L | ||
| Furosemide | 1.59 mg/dL | |
| 48 µmol/L | ||
| Hemoglobin | 1000 mg/dL | |
| 155 µmol/L | ||
| Heparin (sodium) | 330 U/dL | |
| N/A | ||
| Hydralazine hydrochloride | 1.44 mg/dL | |
| 73.2 µmol/L | ||
| Hydrocodone | 0.0072 mg/dL | |
| 0.2 µmol/L | ||
| Ibuprofen | 71 mg/dL | |
| 3.45 mmol/L | ||
| Levothyroxine | 0.0429 mg/dL | |
| 0.552 µmol/L | ||
| Loratadine | 0.0087 mg/dL | |
| 0.227 µmol/L | ||
| Naproxen | 36 mg/dL | |
| 1.43 mmol/L | ||
| Nifedipine | 0.0588 mg/dL | |
| 1.7 µmol/L | ||
| Oleic acid | 40 mg/dL | |
| 0.142 µmol/L | ||
| Omeprazole | 0.840 mg/dL | |
| 24.3 µmol/L | ||
| Phenytoin | 6.00 mg/dL | |
| 238 µmol/L | ||
| Prednisone | 0.010 mg/dL | |
| 0.280 µmol/L | ||
| Propranolol HCl | 0.115 mg/dL | |
| 3.89 µmol/L | ||
| Rheumatoid factor | 900 IU/mL | |
| N/A | ||
| Rivaroxaban | 0.270 mg/dL | |
| 6.19 µmol/L | ||
| Salicylic acid | 2.86 mg/dL | |
| 207 mmol/L | ||
| Streptokinase | 150,000 U/dL | |
| N/A | ||
| Theophylline | 6.0 mg/dL | |
| 333 µmol/L | ||
| Total protein | 15 g/dL | |
| 17.1 nmol/L | ||
| Tissue Plasminogen Activator | ||
| (TPA) | 1.2 mg/dL | |
| N/A | ||
| Triglycerides | 1500 mg/dL | |
| 16.9 mmol/L | ||
| Triolein | 3000 mg/dL | |
| 3.31 µmol/L | ||
| Vancomycin hydrochloride | 12.3 mg/dL | |
| 8.28 mmol/L | ||
| Verapamil | 0.160 mg/dL | |
| 3.52 µmol/L | ||
| Warfarin sodium | 8.0 mg/dL | |
| 242 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 | Correlation
Coefficient | Conventional Units
(ng/mL) | | Alternate Units
(µg/L) | |
|-----------------------------------|-----|-------|----------------------------|--------------------------------|-----------|--------------------------------|-----------|
| | | | | Range of
Sample
Activity | Intercept | Range of
Sample
Activity | Intercept |
| 3600 vs.
Comparative
Method | 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.