(44 days)
For In Vitro Diagnostic Use. This Range+ QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.
Range+ QUALICHECK is a three level quality control system consisting of:
- Range+ QUALICHECK, LEVEL 1 (S7930) .
- Range+ QUALICHECK, LEVEL 2 (S7940) .
- Range+ QUALICHECK, LEVEL 3 (S7950) .
Each level consists of 30 ampoules per box. One ampoule contains 2 mL of solution.
The quality control solution is an aqueous solution containing a biological buffer, salts, glucose, lactate, dyes and a preservative, and it is equilibrated with carbon dioxide and oxygen.
The provided text describes a 510(k) submission for a quality control system, Range+ QUALICHECK, used to evaluate the accuracy and precision of various analytes in blood gas, oximetry, electrolyte, and metabolite measurements. The study presented here is focused on establishing the value assignments and control ranges for the device, rather than proving its acceptance against specific performance criteria in the way one might for a diagnostic test with sensitivity/specificity targets.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a quality control system, so the "performance" here relates to the establishment of its control ranges. The acceptance criteria for the value assignment process are implicitly defined by the methodology used to calculate the target ranges.
| Acceptance Criteria/Methodology | Reported Device Performance (Value Assignment) |
|---|---|
| Ground Truth Establishment: | Twelve ampoules sampled from each of six trays (total 72 ampoules) from the Range+ QUALICHECK batch and 72 ampoules from a reference batch. |
| Samples Conditioned | Conditioned and shaken at 25°C in a water bath for 6 hours. |
| Measurement Devices | Measurements performed on a minimum of 3 validated ABL7xx series devices. |
| Measurement Repetition | Measurement of each parameter performed alternately on reference and sample ampoule, repeated 12 times on each ABL7xx. |
| Control Range Calculation: | Target ranges calculated based on the mean ±2SD of the collected measurements for each analyte. |
| Stability Study: | Real-time stability studies conducted. |
| Shelf Life Claim | Stable for 2 years at 2-8°C. |
| In-use Stability Claim | Ampoules conditioned for at least 5 hours at 18-32℃ before use; contents used immediately after opening. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: For value assignment, 72 ampoules from the Range+ QUALICHECK batch and 72 ampoules from a reference batch were used. Each parameter was measured 12 times on a minimum of 3 devices, leading to at least 144 measurements per parameter. (Calculated as 12 repetitions x 3 devices x 4 ampoules, assuming at least 4 ampoules are measured on each device in an alternating fashion, though the text states "12 times on each ABL7xx for a total of 144 measurements" which suggests 12 measurements per ampoule * 3 devices * 4 ampoules? Or 12 measurements per device for a specific ampoule for a total of 144, if there are 12 different ampoules per device). The more direct reading is 12 repetitions * 3 devices = 36 measurements per ampoule * 4 ampoules measured per device, so 12 * 3 * 4 = 144. However, the text says
12 times on each ABL7xx for a total of 144 measurementsso this means that 12 sample ampoules are measure 12 times on each ABL7xx? The interpretation of12 times on each ABL7xx for a total of 144 measurementsas meaning12 individual tests per ABL7xx * 3 ABL7xx devices * some number of distinct ampoules leading to 144 total measurementsis uncertain. A more direct reading could be 12 individual measurements per ampoule * 12 ampoules = 144, if using only one ABL7xx device? The text could be clearer here. - Data Provenance: The document does not explicitly state the country of origin of the data. Given the submitter's address (Aakandevej 21, 2700 Broenshoej, Denmark), it is strongly implied that the studies were conducted in Denmark or by the submitting company. The study is prospective as it involves controlled measurements to establish values for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for this device is the assigned value and control range for each analyte. This is established through a rigorous measurement process rather than expert consensus on subjective interpretations (like radiology images).
- Number of Experts: Not applicable in the traditional sense of medical expert reviewers. The "ground truth" (assigned values) is determined by the analytical performance of validated ABL7xx series devices and a statistical calculation (mean ±2SD).
- Qualifications of Experts: Not applicable. The "expertise" lies in the validation of the ABL7xx devices and the adherence to the described measurement protocol.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of subjective assessments. The results are quantitative measurements. The "adjudication" is inherent in the statistical calculation of the mean and standard deviation from repeated measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical cases. This device is an in-vitro diagnostic quality control material, and its performance is evaluated through analytical measurements and statistical determination of control ranges, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense relevant to a QC material. The performance described (value assignment and stability) represents the standalone performance of the Range+ QUALICHECK material when analyzed on compatible devices (ABL7xx series). There is no "human-in-the-loop" component for the performance of the QC material itself; it's about the inherent properties and measured values of the solution.
7. The Type of Ground Truth Used
The ground truth used is the assigned values and control ranges derived from repeated analytical measurements on validated laboratory instruments (ABL7xx series devices) using a specified protocol. This is essentially an instrument-derived quantitative ground truth.
8. The Sample Size for the Training Set
The provided text describes the process for value assignment which serves as the "ground truth" or reference for the quality control material. It doesn't explicitly refer to a "training set" in the context of an algorithm or AI model development. The data used for determining the assigned values and control ranges is:
- 72 ampoules from the Range+ QUALICHECK batch.
- 72 ampoules from a reference batch.
- For each parameter, a minimum of 144 measurements (12 repetitions on each of at least 3 validated ABL7xx series devices).
9. How the Ground Truth for the Training Set Was Established
As explained in points 3 and 7, the "ground truth" (assigned values and control ranges) is established through a precise and controlled measurement protocol:
- Multiple ampoules (72 from the new batch, 72 from a reference batch) are prepared by conditioning at 25°C for 6 hours.
- Measurements are performed on a minimum of 3 validated ABL7xx series devices.
- For each parameter, 12 alternating measurements (between sample and reference ampoules) are taken on each ABL7xx device, totaling at least 144 measurements per parameter.
- The target ranges are then calculated as the mean ±2 standard deviations of these collected measurements.
§ 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.