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For the quantitative determination of creatine kinase activity in serum and plasma. Rx only.

Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infaction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

The Pointe Scientific Creatine Kinase (CK) Reagent Set consists of ready-to-use liguid reagents:

• . CK R1 (buffer) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L; NADP 2.0 mmol/L: HK (Baker's yeast) 2.5 KU/L: Glucose 20.0 mmol/L: Magnesium Acetate 10.0 mmol/L; EDTA 2.0 mmol/L and N-acetylcysteine (NAC) 20.0 mmol/L.
• . CK R2 (enzyme reagent) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L: ADP 2.0 mmol/L: AMP 5.0 mmol/L: Diadensosine pentaphosphate 10.0 mmol/L: Creatine phosphate 30.0 mmol/L; G6PDH (Baker's yeast) 1.5 KU/L and EDTA 2.0 mmol/L.

The kinetic procedure presented is a modification of Szasz of the Rosalki technique, which optimizes the reaction by reactivation of CK activity with N-actyl-L-cysteine (NAC).

Creatine Kinase specifically catalyzes the transphosphorylation of ADP to ATP. Through a series of coupled enzymatic reactions, NADPH is produced at a rate directly proportional to the CK activity. The method determines the NADPH absorbance increase per min at 340 nm.

The provided document describes the analytical performance studies for the Pointe Scientific Creatine Kinase (CK) Reagent Set, which supports its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study details:

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

The document doesn't explicitly state "acceptance criteria" in a separate table for each test. Instead, it presents the study results and implies that these results were considered acceptable for demonstrating substantial equivalence. For some tests, like Linearity, an acceptable deviation is stated.

However, based on the provided performance data, we can infer the acceptance criteria that the manufacturer likely aimed for to support their claims.

2. Sample size used for the test set and the data provenance:

• Method Comparison (Serum):
  • Sample Size: 120 de-identified remnant serum samples. 4 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified, but likely within the US given the FDA submission.
• Method Comparison (Plasma):
  • Sample Size: 123 de-identified remnant plasma samples. 2 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified.
• Precision Studies:
  • Sample Size: 2 commercial quality controls, 3 serum pools, and 3 plasma pools. Each pool/control was tested in duplicate twice per day for 20 days (n=80 per sample type).
  • Data Provenance: Not explicitly stated, but common practice is for manufacturers to prepare pools or use commercially available controls.
• Linearity/Assay Range Study:
  • Sample Size: A set of 12 serum samples and 12 plasma samples (prepared by admixture of high-level and low-level pools).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Detection Capability (LoB, LoD, LoQ):
  • LoB: Saline (1 sample * 20 repetitions * 3 days).
  • LoD: 20 low-level depleted serum samples and 20 depleted plasma samples.
  • LoQ: 5 low activity samples (each run in 8 duplicates over 5 days).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Dilution Recovery Studies:
  • Sample Size: Three contrived high-level samples for both serum and plasma.
  • Data Provenance: Not explicitly stated, likely prepared in-house.
• Analytical Specificity (Endogenous Substances):
  • Sample Size: Not explicitly stated, but interference testing was conducted using "randomly selected serum and plasma samples ranging from 43 U/L to 268 U/L."
  • Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a diagnostic reagent for quantitative determination of an analyte (Creatine Kinase), not an imaging or qualitative diagnostic device requiring expert interpretation of results to establish ground truth.

• Ground Truth for Method Comparison: The predicate device's results (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) serve as the "reference" or "ground truth" for comparison. This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices. No human experts are used to establish ground truth in this context; rather, the established method of the predicate device is the reference.
• Ground Truth for other studies (Precision, Linearity, Detection, Dilution Recovery, Specificity): The "ground truth" is typically established by the analytical method itself, or by preparing samples with known concentrations/characteristics, without the need for human expert consensus.

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

No adjudication method is relevant or mentioned as this device measures an objective biochemical marker. The 'ground truth' is the quantitative measurement itself or the reference method's result.

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:

No. This is not applicable. The device is a diagnostic reagent for quantitative measurement of creatine kinase, not an AI-powered diagnostic system for image interpretation or a device requiring human readers/scorers. Therefore, MRMC studies are not relevant.

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

The device is a reagent set used on an automated chemistry analyzer (Shenzhen Mindray BA-800M Chemistry Analyzer). The performance studies presented are for the "algorithm only" in the sense that they demonstrate the analytical performance of the reagent on the analyzer without human interpretation of the raw data to generate the numerical result. The "human-in-the-loop" would be a lab technician performing the test and reviewing the results, but the analytical performance itself is standalone.

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

• Method Comparison: The results obtained from the legally marketed predicate device (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) served as the reference for comparison.
• Precision, Linearity, Detection, Dilution Recovery, Analytical Specificity: Ground truth is based on the inherent analytical properties of the method/reagent including samples with known concentrations (e.g., prepared standards, spiked samples, qualified controls, or established reference material). Linearity was assessed against expected values based on known admixtures. Detection limits were determined using statistical methods on low-level and blank samples.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) submission for a diagnostic reagent. This device is not an AI/machine learning algorithm that requires training data. The studies performed are analytical validation studies.

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

Not applicable, as there is no training set for this type of medical device.

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The Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative determination of benzoylecgonine (a cocaine metabolite) in human urine at a cutoff value of 150 ng/mL. Rx only.

This assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatograph/Mass Spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Cocaine Metabolite Enzyme Immunoassay consists of ready-to-use liquid reagents:

• . Reagent 1 contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers and sodium azide (0.09%) as a preservative.
• Reagent 2 contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with . benzoylecgonine in buffer with sodium azide (0.09%) as a preservative.
  The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody binds to the free drug; the unbound benzovlecgonine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at a 340 nm primary wavelength.
  The assay has a cutoff of 150 ng/mL benzoylecqonine.

Here's an analysis of the provided text to extract the acceptance criteria and study information, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for overall device performance (e.g., "sensitivity must be >X%"). Instead, it presents performance data for several metrics that implicitly represent the device's ability to perform as intended and demonstrate substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Method Comparison: 114 unaltered clinical urine remnant samples.
• Data Provenance: The samples were obtained from a "third-party biorepository." The country of origin is not specified but is implied to be within the scope of the FDA's jurisdiction (likely the US). The data is retrospective as it uses remnant samples.
• Sample Size for Precision Studies: Drug-free urine was spiked at various concentrations (zero, -75%, -50%, -25% of cutoff, at cutoff, +25%, +50%, +75%, +100% of cutoff). For within-run studies, 20 observations were made for each concentration. For between-run studies, 80 observations were made for each concentration.
• Sample Size for Interference Studies: Specific numbers are not given for each interfering substance, but the study involved "various concentrations" for endogenous compounds, and urine samples at 9 different pH levels and 12 different specific gravity levels.
• Sample Size for Cross-Reactivity Studies: "Various concentrations" of structurally related and unrelated compounds were spiked into drug-free urine. Specific numbers of replicates are not provided, except for the referenced study which likely involved a larger set.

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

• The ground truth for the method comparison study was established by Agilent 6460 LC/MS. This is an analytical instrument, not human experts.
• For the precision, interference, and cross-reactivity studies, the ground truth was established by spiking known concentrations of benzoylecgonine or interfering substances into drug-free urine or using urine samples with known characteristics (e.g., pH, specific gravity). This is also an analytical assessment.
• Therefore, no human experts were used to establish the ground truth in the traditional sense of consensus or adjudication. The "ground truth" was determined by the highly precise and accurate analytical methods of LC/MS and controlled spiking.

4. Adjudication Method for the Test Set:

• None. The primary analytical reference method (LC/MS) is considered the gold standard for quantitative determination of benzoylecgonine in this context. The comparison is directly between the candidate device and this analytical gold standard. Discrepancies are reported as "discordant results" without further human adjudication in the provided summary.

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:

• No. This device is an in vitro diagnostic (IVD) assay designed for qualitative determination of a cocaine metabolite in urine. It does not involve human "readers" in the context of image interpretation or subjective diagnostic assessment. Therefore, an MRMC study or AI assistance is not applicable to this type of device.

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

• Yes, this is essentially a standalone algorithm/device performance study. The Pointe Scientific Cocaine Metabolite Enzyme Immunoassay operates as an automated assay on clinical chemistry analyzers (Mindray BS-480 and BA-800M). Its performance is evaluated intrinsically against an analytical gold standard (LC/MS) and under controlled laboratory conditions (precision, interference, cross-reactivity). It does not involve a human in the loop for interpreting its primary result, which is a qualitative "positive" or "negative" determination based on a defined cutoff.

7. The Type of Ground Truth Used:

• Analytical Gold Standard / Spiked Samples:
  • For the method comparison, the ground truth was established by a fully validated and qualified Agilent 6460 LC/MS (Liquid Chromatograph/Mass Spectrometry), which is considered a highly accurate and precise reference method for quantitative drug analysis.
  • For precision, interference, and cross-reactivity studies, the ground truth was established by spiking known, confirmed concentrations of benzoylecgonine or other substances into drug-free urine, or by using urine samples with precisely measured characteristics (pH, specific gravity).

8. The Sample Size for the Training Set:

• The document describes a 510(k) submission for a diagnostic assay, not a machine learning or AI algorithm. Therefore, the concept of a "training set" for an algorithm to learn from does not apply in this context. The assay's performance is based on its chemical and enzymatic reactions, which are designed and validated, not "trained" on data.

9. How the Ground Truth for the Training Set was Established:

• As explained above, there is no "training set" in the context of this chemical immunoassay. The device's operational characteristics are fixed by its chemical and biological components.

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