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K Number
K082227
Device Name
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
Manufacturer
SEBIA
Date Cleared
2009-03-26

(231 days)

Product Code
GKA
Regulation Number
864.7415
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis. For In Vitro Diagnostic Use

Device Description

The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "MINICAP HEMOGLOBIN(E) Kit, Model 2207, 2227." This document certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the specific information requested about acceptance criteria and detailed study results. It is a regulatory clearance document, not a scientific study report or clinical trial summary.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to predicate devices, but doesn't provide specific performance metrics or acceptance criteria used to establish that equivalence.
  2. Sample sizes used for the test set and data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
  6. If a standalone performance study was done: Not explicitly detailed, beyond the claim of substantial equivalence.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on regulatory approval and the device's intended use: "designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System."

§ 864.7415 Abnormal hemoglobin assay.

(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.