(8 days)
ABC Calibration Verifiers is intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs.
ABC Calibration Verifiers should be used any time it is necessary to confirm the proper calibration and linear operating range of TDM methods and instruments. The Clinical Laboratory Improveent Act and its requlations (CLIA) require verification of linearity and calibration twice a year for wodified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new readent lot, major preventative maintenance or replacement of critical parts on the instrument, control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.
ABC Calibration Verifiers is an in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Calibration Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper calibration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Calibration Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 2, 3, and 4 are targeted to be near analyte concentrations of clinical interest. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included. (A second product, ABC Linearity Verifiers, is identical in every respect to this product except that the concentrations of levels 1.2.3, and 4 are related by linear dilution. Both products will perform linear range and calibration verification, and their composition, stabilities and performance are identical except for concentration of middle levels.)
The provided text describes the regulatory clearance of a medical device, the ABC™ Calibration Verifiers, but it does not contain the detailed acceptance criteria or the study data that proves the device meets these criteria in the format requested.
Here's an breakdown of what information is available and what is missing:
Information Provided:
- Device Description: ABC™ Calibration Verifiers is an in vitro diagnostic medical device, a five-level set of verifiers containing 12 analytes made with human serum. It's used to confirm proper calibration, linear operating range, and reportable range (linearity) of Therapeutic Drug Monitoring (TDM) methods.
- Intended Use: To verify the calibration, linear operating range, and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs.
- Predicate Devices: DOCUMENT TDM I Linearity Test Set and LiniCAL Protein I Calibration Verifiers.
- Performance Assessment (General): "The performance of ABC Verifiers has been tested on two commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System and Behring (formerly Syva) EMIT system reagents) and by HPLC methods for selected analytes to validate their use. All methods tested demonstrated the desired functionality of the product."
- Conclusion: The product is substantially equivalent to predicate devices based on purpose, descriptions, labeling, safety, efficacy (using multiple instruments/methods), and stability data.
Missing Information (Crucial for answering the request):
The document provided does not contain any specific, quantitative acceptance criteria or detailed study results that would allow for the completion of the requested table and paragraphs. It states that performance tests were done and "demonstrated the desired functionality," but it doesn't quantify what "desired functionality" means in terms of specific metrics like accuracy, precision, linearity, or error rates.
Therefore, I cannot populate the requested table or answer most of the specific questions.
Attempted Answer based on available information (with significant gaps acknowledged):
The provided 510(k) summary focuses on the substantial equivalence of the ABC™ Calibration Verifiers to predicate devices, rather than a detailed performance study with explicit acceptance criteria. As such, the document does not contain the specific quantitative acceptance criteria or the granular study data to prove the device meets these criteria in the format requested.
The document broadly states: "The performance of ABC Verifiers has been tested on two commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System and Behring (formerly Syva) EMIT system reagents) and by HPLC methods for selected analytes to validate their use. All methods tested demonstrated the desired functionality of the product." However, it does not specify what "desired functionality" quantitatively entails or provide the detailed results of these tests against predefined acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated, Inferred based on device function) | Reported Device Performance (General Statement, No Specific Metrics Provided) |
|---|---|
| Verification of proper calibration of TDM methods | "All methods tested demonstrated the desired functionality of the product." |
| Verification of linear operating range of TDM methods | "All methods tested demonstrated the desired functionality of the product." |
| Verification of reportable range (linearity) of TDM methods | "All methods tested demonstrated the desired functionality of the product." |
| Compatibility with Abbott TDx Assay System | Tested on this system, "demonstrated the desired functionality." |
| Compatibility with Behring (Syva) EMIT system | Tested on this system, "demonstrated the desired functionality." |
| Stability (e.g., 60 days at 2-8°C, etc.) | Stability data generated, contributing to "safety and efficacy" conclusion. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "two commonly used automated therapeutic drug monitoring systems" and "HPLC methods for selected analytes," but the number of samples (runs, replicates, etc.) used for these tests is not provided.
- Data Provenance: Not specified (e.g., country of origin). The testing would have been conducted by SC Calibrators & Controls LLC or a contracted lab. The study appears to be a prospective validation study for the device's market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not mentioned. For calibration verifiers, the "ground truth" is typically established by certified reference materials, gravimetric preparation, or highly accurate reference methods (like HPLC) rather than human expert consensus. The document mentions "Gravimetric + Some Traceable" for calibration.
4. Adjudication method for the test set
Not applicable/Not mentioned. As the ground truth is analytically derived, clinical adjudication by experts is not relevant here.
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 a diagnostic calibrator/verifier, not an AI-powered diagnostic tool requiring human-in-the-loop assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is a physical calibrator. Its "performance" refers to its ability to accurately verify the performance of other diagnostic methods. The tests conducted (on Abbott TDx, Behring EMIT, HPLC) were evaluating the device's function in a standalone manner as a calibrator.
7. The type of ground truth used
The ground truth for the analyte concentrations in the calibrators would have been established through:
- Gravimetric preparation: Quantitatively weighing and dissolving components.
- Assayed calibration: Comparing against highly accurate reference methods (e.g., HPLC for selected analytes) or certified reference materials, as indicated by "Gravimetric + Some Traceable" and the mention of "HPLC methods for selected analytes."
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.