(91 days)
Berichrom Heparin LMW Calibrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of low molecular weight (LMW) heparin.
Benchrom Heparin LMW Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay.
Benchrom Heparin LMW Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay.
Berichrom Heparin LMW Calibrator is a lyophilized product containing low molecular weight (LMW) 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 LMW Control 1 is a lyophilized, low level, assayed control containing low molecular weight (LMW) 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 LMW Control 2 is a lyophilized, high level, assayed control containing low molecular weight (LMW) 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.
The provided text is a 510(k) summary for the Berichrom™ Heparin LMW Calibrator, Berichrom™ Heparin LMW Control 1, and Berichrom™ Heparin LMW Control 2. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the way one might expect for a novel device.
Therefore, many of the requested data points (like sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) are not typically included in a substantial equivalence filing for calibrators and controls used with an existing assay. The document emphasizes similarities in form, matrix, and traceability to previously cleared devices.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the proposed devices (Berichrom Heparin LMW Calibrator, Control 1, Control 2). Instead, it states that the devices are substantially equivalent to their respective predicate devices.
The basis for this substantial equivalence is primarily described as:
- For Berichrom Heparin LMW Calibrator:
- Intended for the calibration of low molecular weight (LMW) heparin.
- Shares similarities in form, matrix, and traceability with the predicate Calibration Plasma LMW Heparin (K030964).
- For Berichrom Heparin LMW Control 1 and Control 2:
- Intended as assayed quality control materials for the measurement of LMW heparin in the low and high concentration range, respectively.
- Shares similarities in form, matrix, and traceability with the predicate Control Plasma LMW Heparin (K030965).
The study proving the device meets these (implied) acceptance criteria is the demonstration of substantial equivalence through comparison to the predicate devices. The document implies that because the proposed devices are essentially identical in function and composition to already cleared devices, their performance for their intended use as calibrators and controls is also equivalent.
2. Sample size used for the test set and the data provenance:
Not explicitly stated for the proposed devices as the core of the submission is demonstrating substantial equivalence rather than a de novo performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a submission for in-vitro diagnostic calibrators and controls, not an AI or imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable.
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 or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used:
For the purpose of this 510(k), the "ground truth" for demonstrating substantial equivalence relies on the established performance and regulatory clearance of the predicate devices:
- Calibration Plasma LMW Heparin (K030964)
- Control Plasma LMW Heparin (K030965)
The expectation is that the new devices, being similar in composition and intended use, will perform interchangeably with these previously cleared products when used with the Berichrom Heparin assay. The underlying "truth" for calibrators and controls is their ability to accurately standardize and monitor an assay's performance against known concentrations, which is assumed to be met if they are substantially equivalent to existing, cleared products.
8. The sample size for the training set:
Not applicable for this type of device and submission. There isn't a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.