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The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.

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The provided text is a 510(k) clearance letter from the FDA for an Immunofixation Electrophoresis Test using the Interlab G26 Instrument. It does not contain information about formal acceptance criteria, device performance reports, or details of a study used to prove the device meets acceptance criteria.

The letter primarily:

• Identifies the device and its regulatory classification.
• States that the device has been determined substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements for the manufacturer.
• Provides the "Indications for Use" for the device, which describes its intended purpose but not performance metrics.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: The document is an FDA 510(k) clearance letter and does not contain detailed acceptance criteria or performance data. It indicates that the device was found "substantially equivalent" to predicate devices, implying that its performance is comparable, but no specific metrics are given.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available in this document.
6. If a standalone performance study was done: Not available in this document.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

The document only provides:

• Device Name: Immunofixation Electrophoresis Test using Interlab G26 Instrument
• Indications For Use: "The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings. The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device."

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