(90 days)
Berichrom Heparin UF Calibrator is an in vitro diagnostic product used for the calibration of the Berichrom Heparin assay for measurement of unfractionated (UF) heparin.
Berichrom Heparin UF Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay.
Berichrom Heparin UF Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay.
Berichrom Heparin UF Calibrator is a lyophilized product containing unfractionated (UF) heparin from porcine intestine and buffered human plasma. Each package contains 6 vials, each vial requires reconstitution with 1.0 mL distilled or deionized water.
Berichrom Heparin UF Control 1 is a lyophilized, low level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma. Each package contains 6 vials, each vial requires reconstitution with 1.0 mL distilled or deionized water.
Berichrom Heparin UF Control 2 is a lyophilized, high level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma. Each package contains 6 vials, each vial requires reconstitution with 1.0 mL distilled or deionized water.
This 510(k) summary describes a submission for a set of calibrators and controls used with an assay to measure unfractionated heparin. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested categories (such as sample size for test/training sets, expert ground truth, adjudication methods, and MRMC studies) are not applicable or provided in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed performance data for the new devices (Berichrom Heparin UF Calibrator, Control 1, and Control 2). Instead, the submission is focused on demonstrating "substantial equivalence" to a predicate device (Dade Behring Heparin Calibrator and Controls - K042941). The "performance" described is the similarity in intended use, form, matrix, and analyte measured, which allows the new devices to be considered equivalent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Proposed devices (Calibrator, Control 1, Control 2) have the same intended use as the predicate devices: calibration for unfractionated heparin measurement (Calibrator) and quality control for low and high ranges of unfractionated heparin (Controls). |
| Form Equivalence | Proposed devices are lyophilized products, similar to the predicate. |
| Matrix Equivalence | Proposed devices contain buffered human plasma, similar to the predicate. |
| Analyte Equivalence | Proposed devices contain unfractionated (UF) heparin from porcine intestine, similar to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for in vitro diagnostic (IVD) calibrators and controls seeking substantial equivalence, not a clinical study requiring test sets with patient data. No specific test set performance data is presented beyond the assertion of similarity to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this type of IVD control and calibrator pertains to their ability to perform their intended function (calibrate or control an assay), which is assessed by manufacturer-defined specifications and comparison to a legally marketed predicate device, not through expert-established ground truth on patient samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication 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 submission is for an in vitro diagnostic calibrator and control, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an in vitro diagnostic calibrator and control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and characteristics of the legally marketed predicate device (Dade Behring Heparin Calibrator and Controls - K042941). The new devices are considered to meet their requirements by demonstrating substantial equivalence to this predicate.
8. The sample size for the training set
Not applicable. This submission doesn't describe a machine-learning device or a training set. The development of IVD reagents typically involves formulation and stability studies, rather than "training sets" in the AI sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 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.