(27 days)
The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Randox Direct LDL/HDL Cholesterol Calibrator is supplied in a kit containing 3x1mls vials. The calibrator contains the analytes LDL and HDL. The base matrix used for the manufacture of Randox Direct LDL/HDL Cholesterol Calibrator is Human Serum. The calibrator contains lipoproteins from the various lipoprotein classes including high density lipoproteins.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Randox Direct LDL/HDL Cholesterol Calibrator:
Acceptance Criteria and Device Performance Study for Randox Direct LDL/HDL Cholesterol Calibrator
Based on the provided K1221266 document, the device described is a calibrator, not a diagnostic device that measures patient samples directly. Therefore, the "acceptance criteria" and "device performance" are focused on its role as a calibration standard and its ability to maintain stability and assignable values. The document primarily describes the characteristics of the calibrator and how its values are assigned, rather than presenting a traditional clinical study with outcome-based performance metrics like sensitivity, specificity, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense for a diagnostic device (e.g., meeting a certain accuracy threshold against a reference standard). Instead, the performance is demonstrated through its stability and the value assignment process, ensuring it reliably provides known concentrations of analytes for instrument calibration.
Acceptance Criteria (Implied from the document's content):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Calibration of Randox HDL and LDL Cholesterol methods. | The device is supplied as a calibrator for this purpose. The value assignment process demonstrates its ability to reliably provide known values for these analytes across multiple analyzer systems. |
| Composition: Contains analytes LDL and HDL in a human serum matrix, with lipoproteins from various classes. | The device description confirms this composition. |
| Stability (unopened): Stable between +2°C and +8°C until the expiry date. | "Unopened Calibrator is stable until the expiry date printed on the product label when stored between +2℃ and +8℃." |
| Stability (reconstituted): Stable for 5 days at +2°C to +8°C and 1 month at -20°C (frozen once). | "Once reconstituted the components are stable for 5 days at +2℃ and +8℃ and 1 month at -20℃ when frozen once." |
| Value Assignment: Assignable target values for Direct LDL and Direct HDL across a range of common clinical chemistry analyzers. | A table is provided showing target values (mmol/l and mg/dl) for both Direct LDL and Direct HDL on 6 different analyzer systems (Abbott Architect c8000, Beckman Coulter AU640, Hitachi 717, Hitachi 911, Randox RX Daytona, Randox Rx Imola, Siemens Advia 1650). |
| Traceability: Analytes are traceable to specific human plasma products. | Traceability information for Direct HDL (Creative Labs 361-10) and Direct LDL (Creative Labs 360-10) from human plasma is provided. |
| Substantial Equivalence: Demonstrated to be substantially equivalent to the predicate device (Teco Diagnostics Direct HDL/LDL Cholesterol Calibrator). | The "CONCLUSION" explicitly states: "Testing results indicate that the proposed device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
For a calibrator, a "test set" in the traditional sense of patient samples is not applicable. The "test set" for this device would refer to the samples used during the value assignment process.
- Sample Size: The document does not specify a distinct "sample size" of individual samples used to determine the values. Instead, it refers to "multiple analysers with reference to a master lot." This implies the calibrator was run numerous times on various instruments. The explicit number of replicates or individual calibrator vials tested for value assignment is not stated.
- Data Provenance: Not explicitly stated, but given Randox Laboratories is a UK-based company and the predicate device comparison table includes international analyzer brands, the testing likely occurred in a controlled laboratory setting (likely in the UK or a partner lab). The data is inherent to the manufacturing and quality control process of the calibrator itself, rather than external patient data. It is a prospective study in the sense that the testing was performed to assign values to the newly manufactured calibrator lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a calibrator, the "ground truth" is established through a hierarchical metrological process, not typically by "experts" reviewing results in the way a radiologist reviews images.
- Number of Experts: Not applicable. The "ground truth" (assigned values) is traceable to established reference materials and methods, often from organizations like the CDC or a certified reference material producer. The document states values are established "with reference to a master lot," which would have its own established traceable values.
- Qualifications of Experts: Not specified or applicable in the context of expert review. The "experts" would be the metrologists and analytical chemists involved in establishing the master lot's values and performing the value assignment on specific instruments, ensuring adherence to rigorous analytical standards.
4. Adjudication Method for the Test Set
Not applicable. As discussed above, the "test set" refers to the value assignment process, which relies on analytical measurements and metrological traceability, not consensus-based adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a calibrator, an in-vitro diagnostic reagent, so an MRMC study is not appropriate or presented.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable to a calibrator. A calibrator does not have an "algorithm" in the sense of an AI or software processing data. Its function is to provide known concentrations for instrument calibration. The "performance" is its ability to consistently deliver these known concentrations and be stable over time.
7. The Type of Ground Truth Used
The "ground truth" for the calibrator's values is established by metrological traceability to a master lot, which in turn is traceable to higher order reference materials and methods. The document explicitly mentions "The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot." And the "Traceability" section identifies the specific human plasma products (Creative Labs) as the origin for the analytes.
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator, not an algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this type of device.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 § 862.9.