(63 days)
ELITech Clinical Systems ISE CONTROL I and ELITech Clinical Systems ISE CONTROL II are control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO2 on ELITech Clinical Systems Selectra analyzers equipped with ISE Module.
ELITech Clinical Systems ISE CONTROL I and ELITech Clinical Systems ISE CONTROL I are two level quality control products consisting of lyophilized human serum with added constituents of purified biochemicals chemicals, therapeutic drugs , preservatives and stabilizers. ISE CONTROL I and ISE CONTROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
The provided document is a 510(k) summary for the ELITech Clinical Systems ISE CONTROL I and CONTROL II. It details the device's characteristics and compares it to a predicate device, concluding with a statement of substantial equivalence. However, the document does not explicitly present acceptance criteria in a table format with reported device performance data, nor does it describe a study to prove those criteria were met in the comprehensive manner requested.
The document is a regulatory submission demonstrating substantial equivalence to a predicate device, which is a different type of evaluation than an independent study focused on predefined acceptance criteria and performance metrics.
Based on the information available in the provided text, I can infer some aspects and highlight what is missing:
Inferred Information:
The core "acceptance criterion" in this context is "substantial equivalence" to the predicate device, the Biorad-Lyphochek Assayed Chemistry Control Level 1 and 2 (K040273). The conclusion explicitly states: "The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate that the salety compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device."
This means the acceptance criteria are implicitly met if the new device performs similarly to the predicate device in terms of its intended use, format, handling, and stability for quality control of ISE Na, K, Cl, Total CO2 measurements.
Missing Information (which would be present in a dedicated study as requested):
- Table of Acceptance Criteria and Reported Device Performance: This would typically list specific quantitative or qualitative thresholds (e.g., "bias must be within X%", "CV must be less than Y%") and then present the ELITech device's actual performance against those thresholds. The current document only shows a side-by-side comparison of device characteristics with the predicate, not performance data.
- Sample Size Used for the Test Set and Data Provenance: The document does not describe a "test set" in the context of performance testing for acceptance criteria. The comparison is based on the characteristics and intended use.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as this is a quality control material and not a diagnostic device requiring expert interpretation for ground truth.
- Adjudication Method: Not applicable for the same reason as above.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a quality control material, not a diagnostic device requiring human-in-the-loop performance evaluation.
- Standalone (Algorithm Only) Performance: Not applicable. This is a chemical control material.
- Type of Ground Truth Used: For quality control materials, the "ground truth" would be the assayed values provided by the manufacturer. The document implies that the device's performance is assessed by its ability to provide stable and reliable control values.
- Sample Size for the Training Set: Not applicable as this is not an AI/ML device requiring a training set.
- How the Ground Truth for the Training Set was Established: Not applicable.
Summary of available information based on the prompt's categories:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred): Substantial equivalence to the predicate device (Biorad-Lyphochek Assayed Chemistry Control Level 1 and 2), meaning similar intended use, format, handling, and stability for quality control of ISE Na, K, Cl, Total CO2.
- Reported Device Performance: The document provides a comparative table of characteristics, but not specific quantitative performance data (e.g., accuracy, precision) against predefined numerical acceptance criteria. The conclusion states that "performance data and other information demonstrate that...it met all acceptance criteria," but these specific data are not presented in the provided text.
Characteristic ELITech Clinical Systems Device (ISE CONTROL I & ISE CONTROL II) Predicate Device (Biorad-Lyphochek Assayed Chemistry Control Level 1 and Level 2) Intended Use Control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO2 on ELITech Clinical Systems Selectra analyzers equipped with ISE module. Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (More general, but includes Na, K, Cl, Total CO2 likely) Format Lyophilized human serum Lyophilized human serum Levels Two levels Two levels Handling/Rx Reconstitute with 5 mL distilled/deionized water, dissolve contents completely by occasional gentle swirling within 30 minutes, avoid foam. Reconstitute with 5.0 mL distilled or deionized water. Replace stopper and allow to stand for 20 minutes, swirling occasionally. Stability (Unreconstituted) When stored at 2-8 °C and protected from light, stable until expiry date. Stable until expiration date at 2-8°C. Stability (Reconstituted) Between 2-8 °C: 7 days. Between -20 and -10 °C: 28 days (frozen once). Store tightly capped and protected from light. 7 days when stored tightly capped at 2-8°C. 30 days at -10 to -20°C. Once thawed, do not refreeze. Device Description Lyophilized human serum with added constituents (purified biochemicals, therapeutic drugs, preservatives, stabilizers). Prepared from blood of donors tested negative for HbsAg, HCV, HIV by FDA-approved methods. (General description of predicate implies similar composition as assayed chemistry control) -
Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" for performance metrics. The underlying data for supporting substantial equivalence would have been generated internally by the manufacturer, likely from a lab setting, but details are not provided.
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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 for a quality control material.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a QC material, not an AI algorithm.
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The type of ground truth used: For a quality control material, the ground truth would be the assigned values or reference values established by the manufacturer through rigorous analytical testing against reference methods or calibrators. The document mentions "performance data," which implies analytical studies were performed to establish these values and stability, but the details are not provided.
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The sample size for the training set: Not applicable (not an AI/ML device).
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided 510(k) summary focuses on demonstrating substantial equivalence based on device characteristics and intended use, rather than presenting a detailed "acceptance criteria" study with specific performance metrics against those criteria. The acceptance criterion is implicitly meeting the performance expectations of a similar, legally marketed predicate 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.