(59 days)
Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A). The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma 1-234 A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range.
This 510(k) summary primarily focuses on establishing substantial equivalence for the "Accucolor High Calibrator" to a previously marketed device, "Sigma Product A7432." The document does not describe a full performance study with acceptance criteria in the typical sense for a new diagnostic device. Instead, it relies on demonstrating that the new calibrator is equivalent to an existing, cleared calibrator.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Used for calibration of ATIII assays. | "Both products [Accucolor High Calibrator (A3089) and Sigma Product A7432] are used for the calibration of ATIII assays." |
| Value Assignment Traceability: Assigned values using a secondary standard traceable to a WHO International Reference Preparation for Antithrombin III. | "Both products have values assigned using a secondary standard, which was assigned from a traceable WHO International Reference Preparation for Antithrombin III." |
| Safety - Communicable Disease Screening: Human source material found negative for HbsAg, HCV, HIV-1, and HIV-2 by approved test methods. | "The human source material from which this product was found negative for HbsAg and for antibodies against HCV, HIV-1, and HIV-2 by approved test methods." |
| Proper Use/Handling: Clear instructions for handling and disposal. | "The 'Precautions' section of the data sheet instructs the user in handling and disposal of this product and directs the user to sources of additional information on the product." |
| Consistency with Normal Range: Provides a reference material with an assigned value slightly above the normal AT-III range. | "The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma (citations provided). A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range." (This is a design feature rather than a specific performance metric of the calibrator itself showing it meets a "normal range" criterion, but it shows it fulfills its intended role by being positioned above the normal range for calibration purposes). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable in the context of a de novo performance study for the calibrator. The primary "study" is a demonstration of substantial equivalence.
- Normal Population Range Determination: A normal population range was determined at Sigma Diagnostics using n=70 samples. The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it was performed "at Sigma Diagnostics." This appears to be a historical determination of a reference range, not a test set for the calibrator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There isn't a "test set" in the sense of clinical samples being evaluated by experts to establish ground truth for the calibrator's performance. The calibrator itself is part of the measurement system's ground truth by providing a known standard.
- The ground truth for the value assignment of both the new and predicate calibrators relies on traceability to a "WHO International Reference Preparation for Antithrombin III," which implies an internationally recognized standard.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication process for a test set is described.
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
- Not applicable. This is not an AI/imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is an in vitro diagnostic calibrator, not an algorithm. Its performance is intrinsic to its chemical properties and assigned value.
7. The Type of Ground Truth Used
- The ground truth for the assigned value of the calibrators (both the new and predicate) is established through traceability to a WHO International Reference Preparation for Antithrombin III. This is an internationally recognized reference standard.
- For the normal population range mentioned, the ground truth was derived from a study of n=70 individuals, defining a normal range (83-119% with a mean of 101.1+9.8).
8. The Sample Size for the Training Set
- Not applicable. There is no training set in the sense of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set. The "ground truth" for the calibrator's value is established by its manufacturing process and traceability to an international reference standard.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.