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510(k) Data Aggregation
(259 days)
The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.
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.
The Creatine Kinase-MB assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.
This document is a 510(k) summary for a medical device called "Creatine Kinase-MB" by Roche Diagnostics. It describes the device, its intended use, technological characteristics, and performance evaluation data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: This document is about a clinical chemistry assay (an in-vitro diagnostic test), not an AI/ML device. Therefore, many of the typical AI/ML study components (like multi-reader multi-case studies, expert adjudication, or separate training/test sets for AI models) are not applicable to this type of device. The "ground truth" here is the reference measurement method or the expected concentration of the analyte.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an in-vitro diagnostic test and not an AI/ML device, the acceptance criteria are not typically expressed as sensitivity/specificity in an MRMC study for diagnostic imaging. Instead, the acceptance criteria relate to analytical performance characteristics. The document presents the performance data against established analytical standards (CLSI guidelines) and comparisons to a predicate device.
| Acceptance Criterion Category | Specific Criterion (Implicit/Explicit from CLSI Guidelines/Industry Standards) | Reported Device Performance |
|---|---|---|
| Precision | Repeatability (Within-run precision): Acceptable CV/SD for varying analyte concentrations. | Human Serum 1 (17.9 U/L): SD 0.4 U/L, CV 2.2% |
| Human Serum 2 (29.1 U/L): SD 0.4 U/L, CV 1.2% | ||
| Human Serum 3 (524 U/L): SD 2.5 U/L, CV 0.5% | ||
| Human Serum 4 (1040 U/L): SD 4.9 U/L, CV 0.5% | ||
| Human Serum 5 (1826 U/L): SD 25 U/L, CV 1.3% | ||
| Intermediate Precision (Within-lab precision): Acceptable CV/SD for varying analyte concentrations. | Human Serum 1 (17.8 U/L): SD 0.5 U/L, CV 2.8% | |
| Human Serum 2 (29.0 U/L): SD 0.6 U/L, CV 1.9% | ||
| Human Serum 3 (531 U/L): SD 4.4 U/L, CV 0.8% | ||
| Human Serum 4 (1040 U/L): SD 8.4 U/L, CV 0.8% | ||
| Human Serum 5 (1851 U/L): SD 42 U/L, CV 2.3% | ||
| Analytical Sensitivity | Limit of Blank (LoB): Should be below claimed limit of quantitation. | Result: 0.3 U/L, Claim: 3 U/L |
| Limit of Detection (LoD): Should be below claimed limit of quantitation and above LoB. | Result: 1.0 U/L, Claim: 3 U/L | |
| Limit of Quantitation (LoQ): The lowest concentration at which quantitative results can be reported with acceptable precision and accuracy. | Result: 1.9 U/L, Claim: 10 U/L | |
| Linearity/Assay Reportable Range | Measurements across the claimed measuring range should be linear with a high correlation coefficient (R2). | Plasma: y=0.969x + 0.210, R2=0.9996 Serum: y=0.992x + 0.306, R2=0.9999 |
| Endogenous Interferences | No significant interference from common interferents up to specified levels. | Conjugated Bilirubin: No significant interference up to 60 I Index (approx. 1026 µmol/L or 60 mg/dL). |
| Lipemia: No significant interference up to 500 L Index. | ||
| Hemolysis: Interferes, hemolyzed samples should not be used. | ||
| Exogenous Interferences (Drugs) | No significant interference from common drugs at therapeutic concentrations. | No interference with common drug panels, except Cyanokit (Hydroxocobalamin) and Cefoxitin. |
| Method Comparison to Predicate | Results should be comparable to the legally marketed predicate device (e.g., strong correlation, slope near 1, intercept near 0). | Regression: y = 0.977x + 1.12, r = 0.968 (105 human serum samples plus 4 spiked samples). |
| Matrix Comparison (Anticoagulants) | Different sample matrices (serum vs. various plasma types) should yield comparable results. | Serum vs. Serum Gel Separation: y = 0.996x + 0.804, r = 1.00 Serum vs. Li-heparin: y = 1.00x - 0.616, r = 0.999 Serum vs. K2-EDTA: y = 1.00x - 0.717, r = 0.999 Serum vs. K3-EDTA: y = 0.995x - 0.062, r = 1.00 |
Study Details:
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision (Repeatability & Intermediate Precision):
- 5 human serum samples and 2 control samples.
- Measurements: Two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory-based prospective testing as per CLSI guidelines.
- Analytical Sensitivity (LoB, LoD, LoQ):
- LoB: One analyte-free sample. Measured with three lots, 10-fold determination in 6 runs, over 3 days (60 measurements per lot).
- LoD: Five samples with low analyte concentration. Measured with three lots, twofold determination in 6 runs, over 3 days (60 measurements per lot).
- LoQ: 5 human serum samples diluted to low levels. Tested in 5 replicates per sample on 5 days, one run per day.
- Data Provenance: Implies laboratory-based prospective testing as per CLSI guidelines.
- Linearity:
- One serum pool and one plasma pool, diluted to 16 (serum) and 18 (plasma) concentrations.
- Measurements: Measured in triplicate.
- Data Provenance: Implies laboratory-based prospective testing.
- Endogenous Interferences:
- Pooled human serum samples spiked with varying levels of interferent.
- Measurements: Tested in triplicate.
- Data Provenance: Implies laboratory-based prospective testing.
- Exogenous Interferences (Drugs):
- Two sample pools (low and high CKMB concentration).
- Measurements: Aliquots spiked with drugs, determined in triplicate.
- Data Provenance: Implies laboratory-based prospective testing.
- Method Comparison to Predicate:
- 105 human serum samples (plus 4 spiked with CK MB rec human).
- Data Provenance: Not explicitly stated origins of human serum samples, but implies prospective collection for this comparison.
- Matrix Comparison (Anticoagulants):
- 31 Li Heparin tubes, 30 K2 EDTA tubes, 31 K3 EDTA tubes, and 31 Gel Separation tubes.
- Data Provenance: Implies prospective collection of samples drawn into different tubes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Ground truth is established by reference methods, known concentrations, or comparison to a predicate device, not by expert medical image interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or adjudication component in the analytical performance testing described for this device. Measurements are objective quantitative values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic imaging tool or a device requiring human readers/interpreters in its primary use.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is fundamentally a "standalone" device in the sense that its performance is measured analytically on its own, producing a quantitative result. There is no "human-in-the-loop" performance as would be relevant for an AI-powered diagnostic imaging tool. The device provides a direct measurement.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance studies is based on:
- Reference Methods/Known Concentrations: For precision, linearity, and analytical sensitivity, samples with known or expected concentrations (e.g., controls, highly purified analytes, or diluted samples) are used.
- Comparison to a Legally Marketed Predicate Device: For method comparison, the results from the new device are compared to those obtained from the established predicate device, which serves as a de facto "truth" or reference standard for equivalence.
- CLSI Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP5-A3, EP17-A2, EP6-A), which define how analytical performance characteristics should be determined using standard laboratory practices.
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 context of model development. The laboratory studies described are for system validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.
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(86 days)
Creatine Kinase is an in vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma on Roche/Hitachi cobas c systems. The determination of CK and CK isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy.
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.
The Creatine Kinase assay is a two reagent assay for the quantitative determination of creatine kinase (CK) in human serum and plasma on automated clinical chemistry analyzers. Photometrically measured NAPDP formation is directly proportional to CK activity in a human sample.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Creatine Kinase Device Performance Study Summary
1. Acceptance Criteria and Reported Device Performance
| Feature / Metric | Acceptance Criteria (Claim in Document) | Reported Device Performance |
|---|---|---|
| Limit of Blank (LoB) | Claim: 7 U/L | 0.3 U/L |
| Limit of Detection (LoD) | Claim: 7 U/L | 1.0 U/L |
| Limit of Quantitation (LoQ) | Claim: 7 U/L | 3.3 U/L |
| Precision (Repeatability) | Achieved with Human Serum samples and PreciControl ClinChem Multi controls. Specific acceptance limits for CV/SD are not explicitly stated as "acceptance criteria" but implied by the presentation of successful results. For example: Human Serum 1 (18.7 U/L) CV <= 3.0%, Human Serum 3 (477 U/L) CV <= 0.6%, PreciControl ClinChem Multi 2 (301 U/L) CV <= 0.4%. | Human Serum 1: Mean 18.7 U/L, SD 0.6 U/L, CV 3.0%Human Serum 2: Mean 137 U/L, SD 0.8 U/L, CV 0.6%Human Serum 3: Mean 477 U/L, SD 3.0 U/L, CV 0.6%Human Serum 4: Mean 946 U/L, SD 5.3 U/L, CV 0.6%Human Serum 5: Mean 1816 U/L, SD 9.4 U/L, CV 0.5%PreciControl ClinChem Multi 1: Mean 154 U/L, SD 0.9 U/L, CV 0.6%PreciControl ClinChem Multi 2: Mean 301 U/L, SD 1.3 U/L, CV 0.4% |
| Precision (Intermediate) | Similar to repeatability, specific acceptance limits for CV/SD are not explicitly stated, but implied by successful results. For example: Human Serum 1 (18.7 U/L) CV <= 3.2%, Human Serum 3 (477 U/L) CV <= 0.6%, PreciControl ClinChem Multi 2 (301 U/L) CV <= 0.9%. | Human Serum 1: Mean 18.7 U/L, SD 0.6 U/L, CV 3.2%Human Serum 2: Mean 137 U/L, SD 1.1 U/L, CV 0.8%Human Serum 3: Mean 477 U/L, SD 3.1 U/L, CV 0.6%Human Serum 4: Mean 946 U/L, SD 5.8 U/L, CV 0.6%Human Serum 5: Mean 1816 U/L, SD 10 U/L, CV 0.6%PreciControl ClinChem Multi 1: Mean 154 U/L, SD 1.7 U/L, CV 1.1%PreciControl ClinChem Multi 2: Mean 301 U/L, SD 2.6 U/L, CV 0.9% |
| Linearity (Serum) | Pearson correlation coefficient (R) of 0.9999 | y=1.001x-0.646, Pearson correlation coefficient (R)=0.9999 |
| Linearity (Plasma) | Pearson correlation coefficient (R) of 0.9999 | y=1.002x-1.205, Pearson correlation coefficient (R)=0.9999 |
| Matrix Comparison (Anticoags) | Good correlation (r >= 0.998) and slope close to 1, intercept close to 0 implied for substantial equivalence. | Serum vs. Serum Gel Separation: y = 0.998x + 0.010, r = 0.999Serum vs. Li-heparin: y = 1.00x - 1.994, r = 0.998Serum vs. K2-EDTA: y = 0.993x - 2.016, r = 0.998Serum vs. K3-EDTA: y = 0.981x - 2.671, r = 0.999 |
| Interference (Hemolysis) | No significant interference up to an H index of 100 (approx. 62.1 µmol/L or 100 mg/dL). | No interference up to Level 1: 103 H Index, Level 2: 130 H Index. |
| Interference (Lipemia) | No significant interference up to an L index of 1000. | No interference up to Level 1: 1356 L Index, Level 2: 1143 L Index. |
| Interference (Unconjugated Bilirubin) | No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approx. 1026 µmol/L or 60 mg/dL). | No interference up to Level 1: 67 I Index, Level 2: 67 I Index. |
| Interference (Conjugated Bilirubin) | No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approx. 1026 µmol/L or 60 mg/dL). | No interference up to Level 1: 68 I Index, Level 2: 76 I Index. |
| Interference (Drugs) | No interference at therapeutic concentrations using common drug panels. (Exception noted for Cyanokit). | No interference found at therapeutic concentrations using common drug panels. (Cyanokit (Hydroxocobalamin) at therapeutic concentrations interferes with the test). |
| Method Comparison (Predicate) | The objective is for results to demonstrate substantial equivalence to the predicate device (COBAS INTEGRA Creatine Kinase, K951595) via Passing Bablok Regression where the slope is close to 1 and the intercept close to 0, and a high correlation coefficient (r). | y = 1.021x + 5.88 U/L, r = 0.999 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Detection Limits (LoB, LoD):
- LoB: One analyte-free sample, measured with three lots, 10-fold determination in 6 runs (total 60 measurements per lot).
- LoD: Five low-analyte concentration samples, measured with three lots, two-fold determination in 6 runs (total 60 measurements per lot).
- Limit of Quantitation (LoQ):
- Five human serum samples, tested in 5 replicates per sample on 5 days.
- Precision (Repeatability & Intermediate):
- Not explicitly stated as a single number, but experiments conducted with multiple human serum samples (5) and control materials (2), with two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
- Linearity (Serum & Plasma):
- Two separate dilution series (serum and plasma), each with 14 concentrations, measured in triplicate.
- Matrix Comparison - Anticoagulants:
- For each of the four tube types (Serum Gel Separation, Li-heparin, K2-EDTA, K3-EDTA), 30 tubes were filled completely. This implies 30 samples for each comparison.
- Interferences - H, L, I Indices:
- Pooled human serum samples spiked with varying levels of interferent. The resulting sample series (10 dilution steps per sample) were tested in triplicate.
- Interferences - Drugs:
- Two sample pools (low and high CK concentrations), divided into aliquots. Each spiked aliquot measured in triplicate.
- Method Comparison to Predicate:
- 132 human serum samples (9 of which were spiked with human recombinant CK MB). Samples tested in singlicate.
Data Provenance: The document explicitly mentions "human serum samples" and "pooled human serum samples." The manufacturer is Roche Diagnostics Operations, located in Indianapolis, IN, USA. Based on the context of FDA submission for a device to be marketed in the USA, it is highly probable the data is retrospective and likely collected in a clinical laboratory setting (possibly in the USA or aligned with international standards like CLSI), but the specific country of origin for the patient samples is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a submission for an in vitro diagnostic device that quantitatively measures a biomarker (Creatine Kinase). The "ground truth" for the test set is established by the reference measurement procedure or the known concentration of the analyte in calibrators/controls, not by expert interpretation of images or clinical data. Therefore, human experts for ground truth adjudication are not applicable in this context.
4. Adjudication Method for the Test Set
N/A. See explanation above. The measurements are quantitative chemical analyses against instrument-derived values and established reference methods/materials, not subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device for quantitative measurement of a biomarker in biological samples. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation plays a significant role, to evaluate how AI assistance impacts human reader performance. This is not applicable here.
6. Standalone (Algorithm Only) Performance Study
Yes, the entire submission is a standalone performance study of the Creatine Kinase assay on the Roche/Hitachi cobas c systems. The device itself is an "algorithm only" in the sense that it is an automated analytical system (reagent + instrument) that produces quantitative results without human intervention in the measurement process itself, beyond sample loading and system maintenance. The studies described (Detection Limits, Precision, Linearity, Interference, Method Comparison) directly assess the performance of this standalone analytical system.
7. Type of Ground Truth Used
The ground truth for the performance studies relies on:
- Reference Materials/Methods: For calibration and verification of accuracy, the method is stated to be traceable to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) Method for Creatine Kinase.
- Known Concentrations: For studies like LoB, LoD, LoQ, linearity, and interference, samples are either analyte-free, spiked with known concentrations of analyte or interferents, or diluted from samples with established reference values. This essentially uses calibrated reference standards and materials as the ground truth.
- Predicate Device Measurements: For method comparison, the predicate device's results (COBAS INTEGRA Creatine Kinase cleared in K951595 on the COBAS INTEGRA analyzer) serve as a comparative ground truth to establish substantial equivalence.
8. Sample Size for the Training Set
N/A. This is not a machine learning or AI-based diagnostic device in the modern sense that requires a "training set" of data to learn from. It is a traditional in vitro diagnostic assay based on a defined enzymatic chemical reaction and photometric measurement. The development of such assays involves extensive research and development to optimize reagents and instrument parameters, but not in the framework of a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
N/A. As explained above, there is no "training set" in the context of an AI/ML device for this product. The development of the assay involves chemical and enzymatic principles, optimized through laboratory experimentation and knowledge of biochemistry, rather than learning from a dataset via a specified ground truth.
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(221 days)
The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Creatine Kinase Liquid Reagent (Kinetic Method)
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"1. A table of acceptance criteria and the reported device performance": null,
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
"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)": null,
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
"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": null,
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
"8. The sample size for the training set": null,
"9. How the ground truth for the training set was established": null
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(52 days)
Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers.
Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
This Reagent is intended for the in vitro quantitative determination of creatine kinase in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the JAS Creatine Kinase (CK-NAC) Liquid Reagent:
Important Note: The provided document is a 510(k) summary for a medical device (a laboratory reagent), not a typical AI/ML device submission. Therefore, many of the requested categories like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only without human-in-the-loop performance)" are not applicable as this is not an AI-powered diagnostic device. The evaluation of this device focuses on its chemical performance and equivalence to existing reagents, not the performance of an algorithm.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Identical to predicate devices. | "The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intended use is identical to predicate Devices." |
| Performance | "Acceptable result comparisons" with predicate devices. | "Correlation studies on human serum demonstrated acceptable result comparisons between these methods" and "it's performance acceptable on the automated chemistry analyzers tested." |
| Normal Ranges | Similar normal ranges to predicate devices. | "which all use similar normal ranges." |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "correlation studies on human serum" but does not provide a specific number of samples or subjects.
- Data Provenance: "human serum." The country of origin is not specified, but given the submitter's address in Miami, Florida, USA, it is likely from the United States. The studies appear to be retrospective or prospective clinical validation studies comparing the new reagent's performance against predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a chemical reagent, "ground truth" is typically established by the reference method or comparison to established, legally marketed predicate devices, not by expert interpretation in the way it would be for an image-based AI diagnostic. The comparison is against established laboratory testing methods.
-
Adjudication method for the test set:
- Not Applicable. As this is a chemical reagent, there's no "adjudication" in the sense of resolving disagreements between human readers or experts. The comparison is quantitative data obtained from automated chemistry analyzers.
-
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:
- No. This is a chemical reagent, not an AI-powered diagnostic device, so an MRMC study is not relevant or applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a lab reagent; there is no "algorithm" in the sense of AI. Its performance is measured as a component of an in vitro diagnostic test system.
-
The type of ground truth used:
- Reference Method/Comparative Performance: The ground truth for evaluating this reagent's performance is established by comparing its results to those obtained using legally marketed predicate devices (Roche Diagnostics CK NAC Reagent and Pointe Scientific Creatine Kinase (CK) Reagent) on automated chemistry analyzers. The aim is to demonstrate "acceptable result comparisons" and "similar normal ranges."
-
The sample size for the training set:
- Not Applicable. This is a chemical reagent; there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML models.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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(28 days)
The Creatine Kinase assay is used for the quantitation of creatine kinase in human 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.
Creatine Kinase (CK) is an in vitro diagnostic assay for the quantitative determination of creatine kinase activity in human serum. The Creatine Kinase assay is a clinical chemistry assay in which creatine kinase in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NAD to NADH. The rate of formation of NADH is monitored at 340 nm and is proportional to the activity of CK in the sample. This reagent also contains AMP and di-(adenosine-5')-pentaphoshate to prevent interference from adenylate kinase.
The Abbott Laboratories Creatine Kinase assay is an in vitro diagnostic device for the quantitative determination of creatine kinase activity in human serum. This 510(k) summary (K981218) submitted in 1998 demonstrates its substantial equivalence to the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (with predicate) | High correlation (e.g., >0.95) | 0.9972 |
| Slope (vs. predicate) | Near 1.0 (indicating proportional agreement) | 1.007 |
| Y-intercept (vs. predicate) | Near 0.0 (indicating minimal constant bias) | -8.757 U/L |
| Total %CV (Precision - Level 1) | Low variability | 2.6% |
| Total %CV (Precision - Level 2) | Low variability | 2.3% |
| Linearity/Assay Range | Comparable to predicate | Up to 2,100 U/L |
| Limit of Quantitation (Sensitivity) | Comparable to predicate | 12 U/L |
Note: The acceptance criteria are "implied by the predicate" as explicit thresholds are not provided in the summary. Substantial equivalence is claimed based on the similarity of performance characteristics to the already marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the comparative performance studies or precision studies. It simply mentions that "comparative performance studies were conducted" and "precision studies were conducted." The data provenance (country of origin, retrospective or prospective) is also not specified, which is common for older 510(k) submissions focusing on in vitro diagnostics. However, given it's a clinical chemistry assay, the samples would likely be human serum.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For in vitro diagnostic assays like this, "ground truth" for the test set is established by comparative measurements against a well-established and legally marketed predicate device (the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay) using clinical samples. It does not involve human expert adjudication in the same way an imaging or diagnostic AI device would. The performance of the predicate device serves as the reference standard.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the ground truth is established by the predicate device's measurements, not human expert adjudication.
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 in vitro diagnostic assay and does not involve human readers interpreting results in a way that would necessitate an MRMC study or an assessment of AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies describe the standalone performance of the Creatine Kinase assay. The stated performance characteristics (correlation, precision, linearity, sensitivity) are inherent to the device itself when processing samples.
7. The Type of Ground Truth Used:
The ground truth for evaluating the Creatine Kinase assay's performance was the measurements obtained from the legally marketed predicate device, the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostics, where a new device's accuracy and reliability are compared to an already accepted method.
8. The Sample Size for the Training Set:
Not applicable. This device is a traditional in vitro diagnostic assay, not an AI/ML-based device that requires a training set in the conventional sense. The "training" for such devices involves reagent formulation, instrument calibration, and optimization based on chemical principles and standard analytical practices, typically using reference materials and established methods rather than large datasets of clinical "training" data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of AI/ML. The "ground truth" for developing and calibrating such a device would be based on:
- Known concentrations/activities: Using certified reference materials or highly characterized samples with known CK activity.
- Reference methods: Comparing results to established, gold-standard laboratory methods (though the predicate device is used for substantial equivalence, not necessarily the primary "ground truth" for initial development).
- Analytical specifications: Ensuring the chemical reactions and detection mechanisms perform according to established scientific principles and expected analytical performance ranges.
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(141 days)
For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.
Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30
The provided text is a 510(k) clearance letter from the FDA for the "Creatine Kinase-SL Assay" and does not contain the detailed information required to describe acceptance criteria and associated study results. The letter confirms substantial equivalence to a predicate device but does not specify performance metrics, study designs, sample sizes, or ground truth methodologies.
Therefore, I cannot provide the requested information based on the given input.
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(54 days)
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Creatine Kinase Reagent. It states that the device has been found substantially equivalent to a predicate device for the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
However, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or training set details. These are typical requirements for device validation studies, but this specific FDA letter is a regulatory clearance document, not a detailed study report.
Therefore, I cannot provide the requested information from the given input.
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(42 days)
Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.
The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).
Here's an analysis of the provided text regarding the Creatine Kinase (CK) Liqui-UV device, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a clinical laboratory device, specifically an in-vitro diagnostic (IVD) test kit. The information provided is primarily for demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study for a novel medical AI device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not provided in the context of an IVD submission of this nature.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Method Comparison (Substantial Equivalence) | Correlation coefficient indicating strong agreement with predicate device. Linear regression showing proportional bias and intercept close to zero. | Correlation Coefficient: 0.999 (with Boehringer Mannheim CK/NAC) Regression Equation: y = 1.027x - 0.65 |
| Precision | Acceptable variability/reproducibility of results. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Linearity | Acceptable performance across a range of analyte concentrations. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Sensitivity | Ability to detect low levels of the analyte. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Stability | Acceptable performance over time under specified conditions. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Interference | Acceptable performance in the presence of common interfering substances. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the method comparison or other performance studies.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, for IVD studies of this type, it's typically a controlled laboratory study using patient samples or spiked samples. It's prospective in the sense that the study was conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this IVD device. The "ground truth" for method comparison is the measurement obtained from the predicate device (Boehringer Mannheim CK/NAC). The performance of the predicate device itself would have been established through its own validation studies. This isn't an image-based AI device requiring expert adjudication.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no expert adjudication process described for establishing ground truth for an IVD test's quantitative results.
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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 in-vitro diagnostic test kit that directly measures a biochemical marker, not an AI-assisted diagnostic imaging or interpretation tool that involves human "readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a "standalone" laboratory test in the sense that its performance is evaluated independent of a human's interpretive input beyond running the assay and reading the result. Its assessment is purely on its analytical performance (accuracy, precision, etc.) in a laboratory setting. There is no "algorithm" in the AI sense for this type of chemical assay.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence and analytical performance is the results obtained from the legally marketed predicate device (Boehringer Mannheim CK/NAC) for method comparison. For other studies like linearity and precision, the "ground truth" is typically established by reference materials, known analyte concentrations, or statistical measures against repeated measurements.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of IVD device.
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(76 days)
For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a Creatine Kinase-MB Reagent Set. This document is a regulatory clearance for an in vitro diagnostic device and does not contain the detailed study information typically found in clinical trials for AI/ML-based medical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input document. The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general regulatory requirements for marketing the device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Details about experts for ground truth establishment or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample sizes for training sets or how their ground truth was established.
This is a clearance letter for a chemical reagent set, not an AI/ML-driven device, so the type of performance data requested is not applicable to this document.
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