(202 days)
For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.
The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.
This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.
Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:
| Feature/Study | Acceptance Criteria (Implied) | Reported Device Performance (SEKURE Creatine Kinase Assay) | Predicate Device Performance (Creatine Kinase-SL Assay) |
|---|---|---|---|
| Intended Use | Quantitative measurement of CK activity in serum. | Quantitative measurement of CK activity in serum and plasma on SK500. | Quantitative measurement of CK activity in serum. |
| Methodology | Must be similar to predicate. | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) |
| Specimen Type | Suitable for reported specimen types. | Serum and lithium heparin plasma. | Serum |
| Measuring Interval | Within a clinically relevant and acceptable range, similar to predicate. | 11-1500 U/L | 2-1500 U/L |
| Precision | Acceptable repeatability and within-laboratory variability (%CV, SD). CLSI EP05-A3 guidelines. | See Section "Precision" table (e.g., Repeatability %CV ranging from 0.6-1.3%, Within Laboratory %CV ranging from 1.2-3.6%). | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Blank (LoB) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 3 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Detection (LoD) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 5 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Quantitation (LoQ) | Clinically acceptable level. CLSI EP17-A2 guidance. | 11 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Linearity/Reportable Range | Observed mean values within ±10% or ±3 U/L of theoretical values. CLSI EP06-A guidance. | Supported measuring range up to 1500 U/L for serum and plasma. | 2-1500 U/L |
| Analytical Specificity (Interference) | Significant interference < 10% difference from control. CLSI EP07-A2 guideline. | No significant interference observed at or below specified concentrations (e.g., Conjugated Bilirubin 40 mg/dL, Hemoglobin 200 mg/dL). | Not explicitly detailed but assumed to meet similar standards. |
| Method Comparison (vs. Predicate) | High correlation (near 1), low bias, slope near 1, small y-intercept. CLSI EP09-A3 guidance. | Lot 1: y-Intercept 2.4 U/L, Corr. Coeff. 0.9998, Bias -2.7%, Slope 0.964. Lot 2: y-Intercept 2.3 U/L, Corr. Coeff. 0.9997, Bias -2.2%, Slope 0.970. | N/A (this is the predicate for comparison) |
| Matrix Comparison (Serum vs. Plasma) | High correlation (near 1), low bias, slope near 1, small y-intercept. | Lot 1: Slope 1.013, y-Intercept -1.8 U/L, Corr. Coeff. 0.9991, Mean Bias 0.9%. Lot 2: Slope 1.015, y-Intercept -3.4 U/L, Corr. Coeff. 0.9991, Mean Bias 0.7%. | N/A |
| Calibration Stability | Clinically acceptable. | 30 days | Not explicitly detailed. |
| Onboard Stability | Clinically acceptable. | 30 days | Not explicitly detailed. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Precision:
- Sample Size: 80 replicates per sample type (Serum Control 1, Serum Control 2, Serum High Pool, Plasma Low Pool, Plasma Med Pool, Plasma High Pool) for each of two reagent lots. Total of 480 measurements per lot.
- Data Provenance: Not explicitly stated, but typical for in vitro diagnostic device studies would be laboratory-generated or purchased control materials and pooled human specimens. The study was conducted in-house by SEKISUI DIAGNOSTICS P.E.I. INC.
- Retrospective/Prospective: Analytical studies like precision are typically prospective, performed under controlled laboratory conditions.
-
Analytical Sensitivity (LoB, LoD):
- Sample Size: 60 measurements for each level (low level samples, saline blanks, dilutions of pooled serum/plasma) for each reagent lot and matrix type.
- Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
- Retrospective/Prospective: Prospective laboratory study.
-
Limit of Quantitation (LoQ):
- Sample Size: 40 replicates (8 linear serum samples, 8 linear plasma samples assayed in 5 runs over 3 days) for each reagent lot and matrix type.
- Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
- Retrospective/Prospective: Prospective laboratory study.
-
Linearity/Assay Reportable Range:
- Sample Size:
- Serum: 8 dilutions of pooled serum, tested in quadruplicate on two lots.
- Plasma: 10 dilutions and admixtures of pooled plasma, tested in quadruplicate on two lots.
- Data Provenance: Pooled serum and plasma likely from human donors, obtained through commercial biospecimen providers or internal collection (with ethics approval).
- Retrospective/Prospective: Prospective laboratory study.
- Sample Size:
-
Analytical Specificity (Interference):
- Sample Size: Minimum of seven interferent concentrations in replicates of five on each of two reagent lots.
- Data Provenance: Laboratory spiked samples using serum.
- Retrospective/Prospective: Prospective laboratory study.
-
Method Comparison with Predicate Device:
- Sample Size: 112 serum specimens, tested in duplicate.
- Data Provenance: Human serum specimens, source not further specified (e.g., country of origin).
- Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.
-
Matrix Comparison (Serum vs. Lithium Heparin Plasma):
- Sample Size: 75 matched serum and lithium heparin plasma specimens, assayed in duplicate.
- Data Provenance: Matched human serum and plasma specimens, source not further specified.
- Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVDD) for Creatine Kinase measurement, which measures a biochemical analyte, does not typically rely on "experts" in the same way an imaging AI device would. The "ground truth" for these studies is established through:
- Reference Methods: For value assignment (e.g., DC-Cal Multi-Analyte Calibrator traceable to an IFCC reference method).
- Highly Characterized Materials: Pooled serum/plasma, control materials with known target values.
- Statistical Analysis: CLSI guidelines (e.g., EP05-A3, EP17-A2, EP06-A, EP07-A2, EP09-A3) provide the statistical framework for defining performance metrics like precision, linearity, and limits of detection/quantitation.
- Comparison to Predicate: The predicate device's established performance serves as a comparative benchmark.
Therefore, there were no specific "experts" (like radiologists interpreting images) establishing ground truth for individual test cases in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for this IVDD study is based on quantitative measurements against reference methods, characterized materials, and statistical analysis, not on subjective interpretations requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are primarily relevant for imaging devices or AI tools where human interpretation of medical images is involved, and the AI's impact on reader performance is being evaluated. This 510(k) is for an in vitro diagnostic assay, which directly measures an analyte concentration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all "standalone" in the sense that they evaluate the performance of the SEKURE Creatine Kinase Assay and the SK500 analyzer system based on their analytical capabilities to directly measure CK activity. There is no "human-in-the-loop" component in the direct measurement process or the evaluation of its analytical performance. The device provides a quantitative result without human interpretive input for the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used here is primarily analytical ground truth based on:
- Reference Methods: Specifically, the CK activity value assignment for DC-Cal is traceable to an IFCC reference method.
- Characterized Materials: Pooled serum and plasma with known or expected CK activity levels derived from rigorous analytical testing.
- Statistical Models: Ground truth for linearity (theoretical values) and detection limits (through statistical calculation as per CLSI guidelines).
- Comparison to a Legally Marketed Predicate Device: The predicate device's performance (Creatine Kinase-SL Assay on a Hitachi 717 Analyzer) serves as a comparative ground truth for demonstrating substantial equivalence.
8. The sample size for the training set
This submission pertains to the performance validation of a diagnostic assay (reagents and analyzer), not a machine learning or AI algorithm in the traditional sense that requires distinct "training sets" and "test sets" for model development and validation. Therefore, there is no explicit separate "training set" described for an AI model.
The "training" of such a system involves the development and optimization of the assay chemistry and instrument parameters. The data presented here are part of the verification and validation (V&V) studies conducted on the final product to demonstrate its performance characteristics and substantial equivalence, akin to a "test set" for a traditional product.
9. How the ground truth for the training set was established
As there isn't a "training set" in the context of an AI algorithm, the concept of establishing ground truth for it doesn't apply directly here. The development of the assay involves standard analytical chemistry principles, optimization of reagent concentrations, reaction conditions, and instrument calibration, with performance iteratively assessed against established analytical standards and clinical relevance. This is an engineering and chemistry development process rather than an AI model training process that relies on labeled datasets.
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This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR §807.92. This is a Traditional 510(k).
K182702 The assigned 510(k) number:
Applicant Information and Date [807.92 (a)(1)]
| Applicant Name and Address: | SEKISUI DIAGNOSTICS P.E.I. INC.70 Watts AvenueCharlottetown, PECanada, C1E 2B9Establishment Registration Number: 8020316 |
|---|---|
| Application correspondent: | Jeanna MacLeodRegulatory Affairs Specialist902-628-0207Jeanna.MacLeod@sekisui-dx.com |
| Date Summary prepared: | April 10, 2019 |
Device Name and Classification [807.92 (a)(2)]
| Trade Name | Common Name | Classification Name | Classification | Product Code |
|---|---|---|---|---|
| SEKURE Creatine Kinase Assay | Creatine Kinase Assayor CK Assay | Creatine phosphokinase/creatine kinase orisoenzymes test system | Class II21 CFR 862.1215 | CGS |
Identification of Legally Marketed Predicate Devices [807.92 (a)(3)]
| Predicate Device | Predicate 510(k) Number |
|---|---|
| Creatine Kinase-SL Assay | K973999 |
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Device Description [807.92 (a)(4)]
| Trade Name | Device Description |
|---|---|
| SEKURECreatine KinaseAssay | The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupledenzyme assay for the quantitative measurement of creatine kinase (CK) activity.The assay consists of two working reagents, a buffer solution (R1) and a substratereagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, toproduce adenosine triphosphate (ATP). The reaction is coupled to hexokinase andG6PDH which consumes ATP to generate NADPH. The rate of NADPH formationis monitored at 340 nm and is directly proportional to CK activity.Testing is performed on the SK500 in conjunction with calibrator and controlswhich are provided separately. |
| SK500 ClinicalChemistryAnalyzer | The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo BoekiMedisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled namefor the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument. |
Intended Use [807.92 (a)(5)]
For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
| Technological Similarities and Differences to the Predicate [807.92 (a)(6)] | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------------------------------------------- |
| Characteristic | Predicate Device | New Device |
|---|---|---|
| Intended Use | Creatine Kinase-SL AssayFor the in vitro quantitativemeasurement of creatine kinase activityin serum. | SEKURE Creatine Kinase AssaySimilarFor the in vitro quantitativemeasurement of creatine kinase activityin serum and plasma on the SK500Clinical Chemistry System. |
| Platform | Hitachi 717 Analyzer (K953239) | SK500 Clinical Chemistry Analyzer |
| Methodology | Colorimetric (NADPH), Enzymatic(coupled hexokinase-G6PD) | SAME |
| Specimen type | Serum | SimilarSerum and lithium heparin plasma |
| Measuring interval | 2-1500 U/L | Similar11-1500 U/L |
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Summary of Non-Clinical Performance Data [807.92 (b)(1)]
Precision
Testing was conducted as per CLSI EP05-A3 using two lots of SEKURE CK reagents on one SK500 instrument. Two levels of sera controls, one level of pooled serum, and three levels of pooled plasma were assayed in duplicate in two runs per day for twenty (20) days. The CK activity data (U/L) are summarized in the following table.
| Lot | Sample | N | Mean CK | Repeatability | Within Laboratory | ||
|---|---|---|---|---|---|---|---|
| (U/L) | SD | %CV | SD | %CV | |||
| Lot 1 | Serum Control 1 | 80 | 145.3 | 1.6 | 1.1 | 2.5 | 1.7 |
| Serum Control 2 | 80 | 438.1 | 3.2 | 0.7 | 6.0 | 1.4 | |
| Serum High Pool | 80 | 772.2 | 5.3 | 0.7 | 13.4 | 1.7 | |
| Plasma Low Pool | 80 | 155.9 | 1.9 | 1.2 | 3.4 | 2.2 | |
| Plasma Med Pool | 80 | 372.3 | 3.1 | 0.8 | 7.7 | 2.1 | |
| Plasma High Pool | 80 | 576.5 | 3.4 | 0.6 | 20.0 | 3.5 | |
| Lot 2 | Serum Control 1 | 80 | 143.3 | 1.7 | 1.2 | 2.4 | 1.7 |
| Serum Control 2 | 80 | 436.9 | 3.3 | 0.8 | 5.3 | 1.2 | |
| Serum High Pool | 80 | 773.9 | 4.8 | 0.6 | 13.8 | 1.8 | |
| Plasma Low Pool | 80 | 153.5 | 2.0 | 1.3 | 3.3 | 2.1 | |
| Plasma Med Pool | 80 | 370.6 | 2.6 | 0.7 | 7.2 | 1.9 | |
| Plasma High Pool | 80 | 574.2 | 3.8 | 0.7 | 20.4 | 3.6 |
Analytical Sensitivity
Limit of Blank (LoB) and Limit of Detection (LoD)
Limit of Blank and Limit of Detection testing was based on guidance from the CLSI guidance document EP17-A2. Testing was completed by analyzing low level samples (saline blanks and dilutions of pooled serum or plasma in saline) in quadruplicate for three days producing a total of 60 measurements of each level. All samples were assayed on two lots of CK reagents and one SK500 analyzer. The LoB and LoD were determined individually for each reagent lot, dilution level, and matrix type; the maximal values are claimed for the SEKURE CK Assay.
| Parameter | CK Activity |
|---|---|
| LoB | 3 U/L |
| LoD | 5 U/L |
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Limit of Quantitation (LoQ)
Limit of Quantitation testing was based on guidance from the CLSI guidance document EP17-A2. Eight linear serum samples and eight linear plasma samples were assayed in five runs over three days to give 40 replicates. All samples were assayed on two lots of CK reagents and one SK500 analyzer. The LoQ was determined as the lowest CK value at which the %CV was determined individually for each reagent lot and each matrix type; the maximal value is claimed as the LoQ for the SEKURE CK Assay. The LoQ claimed is 11 U/L.
Linearity/Assay Reportable Range
A linearity study was performed based on guidance from the CLSI guidance document EP06-A. Linearity testing for serum was conducted using eight dilutions of pooled serum to generate a CK activity range from 0 - 1650 U/L. Linearity testing for plasma was conducted using ten dilutions and admixtures of pooled plasma to generate a CK activity range from 3 - 2700 U/L. All samples were run in quadruplicate on two lots of SEKURE CK reagents and one SK500. The sample observed mean values were within ± 10% or ± 3 U/L of the sample theoretical values across all sample concentrations. The serum and plasma linearity data support the measuring range claim up to 1500 U/L for the SEKURE CK Assay.
Traceability, Stability, Expected Values (controls calibrators or methods)
Value Assignment
Calibration and control material are provided separately. Sekisui DC-Cal Multi-Analyte Calibrator (Cat. SE-035, Product Code JIX, 510(k) Exempt) and DC-Trol Multi-Analyte Controls (Parts SM-052 and SM-056. Product Code JJY, 510(k) Exempt) are recommended for use with the SEKURE Creatine Kinase Assay. The CK activity value assignment for DC-Cal is traceable to an IFCC reference method.
Stability
Product stability has been previously established as 18 months at 2-8°C. The product stability is verified by annual long-term stability testing conducted at half-expiry (9 months) and one-month past expiry (19 months).
Onboard Stability of SEKURE CK on the SK500 analyzer was demonstrated to be 30 days. Calibration stability for CK using the DC-Cal Multi-Analyte calibrator on the SK500 was determined to be 30 days.
Analytical Specificity
An interference study was performed based on the CLSI EP07-A2 guideline to assess common or known substances that could interfere with the CK Assay. Interference testing was conducted using two lots of SEKURE CK reagents. All interferents were tested according to the paired difference method with CK activity levels of 180 and 415 U/L and a minimum of seven interferent concentrations in replicates of five on each reagent lot. Testing was performed using serum only, plasma data is expected to be similar. Significant interference was identified as a percent difference greater than 10% from control.
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| Potential Interferent | Highest Tested Concentration at which no significantinterference was observed | |||
|---|---|---|---|---|
| Conventional Units | SI Units | |||
| Conjugated Bilirubin | 40 mg/dL | 475 umol/L | ||
| Unconjugated Bilirubin | 40 mg/dL | 684 umol/L | ||
| Hemoglobin | 200 mg/dL | 31 umol/L | ||
| Intralipid | 1000 mg/dL | 11.3 mmol/L | ||
| Ascorbic Acid | 3 mg/dL | 170 umol/L |
The interference study results are summarized in the following table:
Summary of Method Comparison
Method Comparison with Predicate Device
Method comparison testing was conducted based on CLSI EP09-A3 on using two lots of SEKURE CK reagents on one SK500 instruments and two lots of SEKURE CK reagent on the Hitachi 717 (predicate). A set of 112 serum specimens were tested in duplicate over five or more operating days. The CK activity of the samples ranged from 23 to 1413 U/L. The regression was generated using first replicate data from the candidate method and mean sample values from the predicate method and is summarized in the following table.
| Deming Regression | Lot 1 | Lot 2 |
|---|---|---|
| y Intercept (U/L) | 2.4 | 2.3 |
| Correlation Coefficient | 0.9998 | 0.9997 |
| Bias | -2.7% | -2.2% |
| Slope | 0.964 | 0.970 |
Matrix Comparison
Matrix comparison testing was conducted to evaluate the suitability of lithium heparin with the SEKURE CK Assay on the SK500. A set of 75 matched serum and lithium heparin plasma specimens were assayed in duplicate using two lots of CK reagents on the SK500. The CK activity ranged from approximately 35 to 1500 U/L. The regression was generated using first replicate data from plasma and mean sample values from serum and is summarized in the following table.
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| Deming Regression | Lot 1 | Lot 2 |
|---|---|---|
| Slope | 1.013 | 1.015 |
| y Intercept (U/L) | -1.8 | -3.4 |
| Correlation Coefficient | 0.9991 | 0.9991 |
| Mean Bias (%) | 0.9 | 0.7 |
Clinical studies
(clinical sensitivity, clinical specificity, other clinical supportive data)
Not Applicable
Expected values/Reference Range
The IFU for the SEKURE CK Assay includes the following statement on reference intervals:
Males: 46-171 U/L (37°C) Females: 34-145 U/L (37°C)
(Rifai, N .; Horvath, A.R .; Wittwer, C., (Eds). Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Sixth Edition. Elsevier, St. Louis, Missouri (2018), p. 409-11)
These values are suggested guidelines. It is recommended that each laboratory establish the normal range for the area in which it is located.
Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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April 17, 2019
SEKISUI DIAGNOSTICS P.E.I. INC. Jeanna MacLeod Regulatory Affairs Specialist 70 Watts Avenue Charlottetown, PEI C1E 2B9 Canada
Re: K182702
Trade/Device Name: SEKURE Creatine Kinase Assay Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: March 20, 2019 Received: March 21, 2019
Dear Jeanna MacLeod:
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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
§ 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.