(28 days)
COMBITROL TS / AUTOTROL TS assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI, alpha series instruments for the analytes listed in the package insert.
As a part of the quality control program in institutions reporting those analytes listed in the package insert, COMBITROL TS and AUTOTROL TS Multi-Analyte Controls should be used in Roche OMNI, alpha series instruments to evaluate test precision and to detect systematic analytical deviations in those laboratories choosing to use a traditional, liquid, quality control product.
COMBITROL TS / AUTOTROL TS is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the Roche OMNI, alpha series analyzers. It contains a stable suspension of polystyrene microbeads which series and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the Roche OMNI, alpha series analyzers. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. metobeaus to simulate tons in the provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.
COMBITROL TS / AUTOTROL TS contain clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, lithium, ionized 1 002, 1 02, 80drains) lactate, urea, creatinine and suitable concentrations of microbeads to simulate clinically relevant values of tHb, hematocrit and oxygen saturation.
The provided text does not contain specific acceptance criteria or a detailed study proving that the device meets such criteria in the quantitative sense often associated with AI/ML-driven devices (e.g., sensitivity, specificity, accuracy targets). This document is a 510(k) summary for a medical device cleared in 2001, which predates the widespread use of AI/ML in medical devices and the associated regulatory expectations for performance studies.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. The "study" proving the device meets the acceptance criteria is implicitly the comparison of its characteristics to those of the predicate devices.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there are no explicit quantitative acceptance criteria or a performance table in the AI/ML context. The implicit "acceptance criterion" is functional and technological equivalence to predicate devices. The "reported device performance" is a description of its characteristics and intended use, demonstrating this equivalence.
| Characteristic | Predicate Devices (COMBITROL PLUS, AVL OPTI-check PLUS) | Modified Device (COMBITROL TS / AUTOTROL TS) | "Acceptance Criteria" Met? (Implicit) |
|---|---|---|---|
| Device Name | COMBITROL PLUS Multi-Analyte Control, AVL OPTI-check PLUS Multi-Analyte Control | COMBITROL TS / AUTOTROL TS Multi Analyte Controls | Yes (Functionally Equivalent) |
| 510(k), Date | K972868, 08/28/97; K913133, 09/27/91; K001632, 06/19/00 | N/A (New Device) | N/A |
| Number of levels | 3 | 3 | Yes |
| Analytes | pH, PCO2, PO2, Na+, K+, Cl-, iCa++, Li+, iMg++, tHb, Hb derivatives, Urea, Glucose, Lactate, Creatinine (for COMBITROL PLUS); pH, PCO2, PO2, Na+, K+, Cl-, iCa++, Urea, Glucose tHb, SO2 (for AVL OPTI-check PLUS) | pH, PCO2, PO2, Na+, K+, Cl-, iCa++, Li+, iMg++, tHb, Hct, SO2, Urea, Glucose, Lactate, Creatinine | Yes (Comparable analytes, expanded for new device) |
| Container | glass ampoule | glass ampoule | Yes |
| Fill volume | 1.7 mL | 1.7 mL | Yes |
| Color | red (COMBITROL PLUS); milky (AVL OPTI-check PLUS) | milky | Yes (Similar to one predicate) |
| Matrix | HEPES based aqueous with dyes to simulate Hb and derivatives (COMBITROL PLUS); HEPES based aqueous with polystyrene beads to simulate Hb and SO2 (AVL OPTI-check PLUS) | HEPES based aqueous with polystyrene beads to simulate Hb and SO2 | Yes (Similar to one predicate, specifically AVL OPTI-check PLUS) |
| Intended Use | General control solutions | To monitor and evaluate the analytical performance of the Roche OMNI, alpha series instruments for the analytes listed in the package insert. | Yes (Similar function) |
| Technological Characteristics | HEMES based aqueous matrix, glass ampoule, 3 levels. Some predicates use dyes, others use polystyrene beads for Hb/SO2 simulation. | HEPES based aqueous matrix, glass ampoule, 3 levels. Uses polystyrene beads to simulate tHb, Hct, SO2. | Yes (Similar to predicate that uses polystyrene beads) |
2. Sample Size Used for the Test Set and Data Provenance
This is an in-vitro diagnostic (IVD) control solution, not typically subject to the same "test set" and "data provenance" requirements as AI/ML software. The "testing" involved demonstrating the chemical and physical characteristics of the control solution itself and its behavior in the target instrument.
- Test Set Sample Size: Not applicable in the AI/ML sense. The "test" here refers to non-clinical tests (e.g., accelerated aging studies) for stability and formulation comparison against predicate devices. No specific number of "samples" or "cases" for a diagnostic algorithm is mentioned.
- Data Provenance: Not applicable for this type of IVD control. The "data" would be analytical measurements from the control solution itself when run on a Roche OMNI, alpha series analyzer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For IVD control solutions, "ground truth" is typically established by certified reference materials, reference methods, or traceable analytical measurements, not by human expert consensus on images or diagnostic outcomes.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. "Adjudication" is relevant for determining ground truth in ambiguous cases, usually in image interpretation or clinical diagnosis. For a chemical control, the "truth" is determined analytically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- MRMC Study: No, an MRMC study was not done. An MRMC study is relevant for AI-assisted diagnostic tools where human readers are interpreting cases. This device is a quality control solution for an instrument.
- Effect Size of Human Readers Improvement with AI: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a consumable control solution, not an algorithm. Its performance is evaluated by how accurately it reflects known analyte concentrations when run on a diagnostic instrument.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a multi-analyte control solution, the "ground truth" for the concentrations of the various analytes (pH, PCO2, PO2, Na+, K+, etc.) would be established by reference methods and certified materials, typically calibrated by highly accurate laboratory instruments. For the simulation aspects (tHb, Hct, SO2 using microbeads), the performance is compared against the expected behavior of these analytes in actual blood samples on the target instrument.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
Summary of the Study Proving Acceptance Criteria:
The study that "proves the device meets acceptance criteria" is implicitly the submission of non-clinical tests and a comparison to predicate devices.
- Non-clinical tests: The document states "Accelerated aging studies on most labile analytes, together with experience with other products with similar formulations support stability claim." These studies would demonstrate that the control solution maintains its specified characteristics over time.
- Substantial Equivalence Argument: The core of the 510(k) submission is the detailed comparison of the new device's characteristics (analytes, matrix, levels, container, fill volume, intended use) to those of legally marketed predicate devices. By showing that the COMBITROL TS / AUTOTROL TS is similar in design, materials, and intended use to existing devices, Bionostics, Inc. argues that it is equally safe and effective. The FDA's clearance (K012431) signifies their agreement that this claim of substantial equivalence is met.
In conclusion, the document describes a traditional 510(k) submission for an IVD control solution, where "acceptance criteria" are met by demonstrating substantial equivalence to predicate devices and inherent stability through non-clinical testing, rather than through performance metrics for an AI/ML algorithm.
§ 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.