(148 days)
The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.
The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation. The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye and Reference Standard). ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.
Here's a breakdown of the acceptance criteria and study findings for the ALKO Diagnostics Corporation's tHb Cal Standard, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ALKO tHb Cal Standard are implicitly defined by its equivalence to the predicate device, Instrumentation Laboratory's Cal Dye™ Reference Standard, and its ability to consistently calibrate CO-Oximeters and Oximeters within acceptable ranges. The performance metrics reported are precision (as Total and Run-to-Run CV%) and comparative agreement with assayed values and the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance and Comparisons |
|---|---|---|
| Precision | The ALKO tHb Cal Standard should demonstrate precision comparable to or better than established industry standards for similar calibrators and allow the CO-Oximeter/Oximeter to maintain precision for control analyses. (Specific numerical criteria are not explicitly stated, but typical expectations for calibrators in high-precision medical devices are very low CV%). | Precision Data (IL 482 analyzer, calibrated with ALKO tHb Cal Standard, using IL CO-OX controls): |
- Level 1 (Mean 16.9): Total CV% 0.6993, Run to Run CV% 0.3826
- Level 2 (Mean 13.8): Total CV% 0.8340, Run to Run CV% 0.5857
- Level 3 (Mean 7.2): Total CV% 1.0758, Run to Run CV% 0.7435
These CV% values are very low, indicating high precision. |
| Comparative Data (tHb Cal Standard vs. Predicate) | The ALKO tHb Cal Standard should yield total hemoglobin (tHb) values that are effectively equivalent to those obtained with the IL Cal Dye™ Reference Standard when measured on the same IL CO-Oximeters/Oximeters. The mean tHb values, standard deviations, and CV% should be very similar, and the measured range (min-max) should encompass or align closely with the assayed values and the predicate's performance. Consistency across different instrument models (IL 282, IL 482) is also a criterion. | On IL 282:
- IL 33150 (Predicate): Mean 14.7, STD 0.0653, CV% 0.4450, tHb min.-max. 14.6-14.8, Assay Value 14.8
- ALKO A331-50: Mean 15.0, STD 0.0499, CV% 0.3316, tHb min.-max. 15.0-15.1, Assay Value 15.0
On IL 482:
- IL 33150 (Predicate): Mean 14.9, STD 0.0730, CV% 0.4901, tHb min.-max. 14.8-15.0, Assay Value 14.9
- ALKO A331-50: Mean 14.8, STD 0.0442, CV% 0.2993, tHb min.-max. 14.7-14.8, Assay Value 14.8
The mean tHb values, SDs, and CV% are very close between the ALKO and IL products on both instruments, demonstrating strong agreement and comparability. The measured ranges are also consistent with the respective assayed values. |
| Functional Equivalence (with predicate) | When used to calibrate IL CO-Oximeters/Oximeters, the ALKO tHb Cal Standard should enable the instrument to produce mean values for various blood gas parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb) from control samples that fall within the assayed control ranges and are comparable to results obtained when the instrument is calibrated with the predicate IL Cal Dye™ Reference Standard. | On IL 282 & IL 482: For all three control levels and across all measured parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb), the mean values obtained when calibrating with ALKO tHb Cal Standard are very similar to those obtained with the IL Cal Dye™ Reference Standard. Critically, these mean values consistently fall within the specified "Assayed Control Values" ranges, which broadens the acceptance window. The results demonstrate that the ALKO calibrator allows the instruments to perform functionally equivalently to calibration with the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set: The precision study used three levels of IL CO-OX controls. Each level was analyzed 3 times per run, for 5 runs, after a separate calibration for each run. This totals 15 data points (N=15) for each level for "Total" precision, and 5 data points (N=5) for "Run to Run" precision (representing the 5 runs).
- Comparative Data Test Set: For both the IL 282 and IL 482 analyzers, 15 measurements (N=15) were taken for both the IL predicate product and the ALKO product.
- Functional Tests Test Set: Three levels of IL CO-OX controls were measured in triplicate (meaning 3 measurements per level). This was done after calibrating separately with the ALKO standard and the IL predicate standard. (The exact total number of individual measurements for functional tests across all parameters is not explicitly stated as 'N' in a table, but it implies 3 measurements * 3 levels * 2 calibration methods * number of parameters).
- Data Provenance: The data was generated by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746, USA. This indicates the testing was done in the USA. The study appears to be prospective as it involves direct testing and comparison of the ALKO product against the predicate and control materials with specific measurement protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth is established through:
- Assayed values: For the comparative data and functional tests, "Assay Value" or "Assayed Control Values" are provided, which represent the target or expected values for the control materials. These values are typically established by the control manufacturer using reference methods or multiple laboratory testing, not by ad-hoc experts for this specific study.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of expert review. The study relies on direct quantitative comparison of instrument readings against established assay values or predicate device performance.
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
This is not applicable as the device is an in-vitro diagnostic solution (calibrator) for an instrument, not an AI-powered diagnostic imaging or decision support tool that is interpreted by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is standalone performance in the context of an IVD calibrator. The performance of the ALKO tHb Cal Standard is assessed by its direct functional impact on the IL CO-Oximeters/Oximeters, allowing them to accurately measure control samples. There is no "human-in-the-loop" interpretation beyond the operation of the instrument itself. The study objective is to show the calibrator functions on its own to enable accurate instrument readings.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used consists of:
- Assayed Values: These are reference values provided by the manufacturer of the IL CO-OX controls for specific parameters (tHb, %O2Hb, etc.). These are typically established through rigorous analytical testing using reference methods.
- Predicate Device Performance: The performance of the Instrumentation Laboratory Cal Dye™ Reference Standard is used as a direct benchmark, as the ALKO product is intended to be a direct replacement and functionally equivalent. The equivalence to an already marketed and presumably validated product serves as a form of "ground truth" for comparative studies.
8. The Sample Size for the Training Set
This is not applicable. The ALKO tHb Cal Standard is an in-vitro diagnostic reagent (calibrator), not an algorithm or AI model that requires a training set. The "composition, description and packaging design" mention indicates a manufacturing process, not a machine learning process.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned for this product.
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.