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The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 Antitrypsin deficiency. The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the SPIFE A1AT kit does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlines general regulatory requirements. It does not include the specifics of the performance study, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Details about expert involvement in ground truth establishment or adjudication methods.
• Information on MRMC studies or effect sizes.
• Whether standalone performance was evaluated.
• The type of ground truth used.
• How ground truth was established for the training set.

To obtain this information, you would typically need to refer to the 510(k) summary or the full 510(k) submission for the device, which are often available through the FDA's public databases or directly from the manufacturer. The clearance letter itself only confirms the regulatory approval.

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The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings.

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I am sorry, but the provided text is a regulatory clearance letter from the FDA and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The document states that the device, "SPIFE® IFE-3 Pentavalent Kit, SPIFE® IFE-6 Pentavalent Kit, SPIFE® IFE-9 Pentavalent Kit, SPIFE® IFE-15 Pentavalent Kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" as: "The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings."

However, it does not provide any specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets), details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, ground truth, training set information), or effectiveness studies (MRMC or standalone performance).

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The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis

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The provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE 3000 Titan Gel IgG IEF Kit". This document primarily focuses on regulatory approval based on substantial equivalence, and not on the detailed reporting of a study that establishes acceptance criteria and proves the device meets them in the way modern AI/ML device submissions would.

Therefore, the information you're requesting regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

The document states the indications for use: "The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis."

However, it does not include the detailed performance study results that would typically define "acceptance criteria" and "reported device performance" in the format you've requested. The FDA's 510(k) clearance process for this type of device (from 2003) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, de novo clinical trial data with predefined acceptance metrics and detailed statistical analysis on a test set.

In summary, the input text does not contain the information necessary to fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes and data provenance for test sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for the "SPIFE CK Kit". It states that the device is substantially equivalent to a legally marketed predicate device for the identification and quantitation of serum creatine kinase isoenzymes, particularly useful in detecting acute myocardial infarction. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts, adjudication methods, or ground truth establishment for a test set.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
5. Information about a standalone algorithm performance study.
6. Details on the type of ground truth used.
7. Sample size for a training set or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

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The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or the study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for a device called "SPIFE LD-12 Isoenzyme Kit."

This letter primarily focuses on:

• Substantial Equivalence: Stating that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Classification: Identifying the regulation number, name, and regulatory class (Class II).
• General Controls: Informing the manufacturer about applicable general controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Marketing Authorization: Granting permission to market the device.
• Indications for Use: Briefly describing the intended use of the device in relation to diagnostic conditions such as myocardial infarction, skeletal muscle injury, and lymphatic system involvements.

The document does not contain data tables, sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results from any performance studies (standalone or MRMC).

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The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE Lipoprotein-12 System." This document does not contain the detailed information required to describe the acceptance criteria, study design, or performance metrics in the format requested.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or expert details for ground truth.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Details on the type of ground truth used or the training set sample size and its ground truth establishment.

The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed, and it outlines the indications for use. It does not delve into the specifics of validation studies.

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The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.

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This document is a 510(k) clearance letter from the FDA for the SPIFE 2000/3000 ALP device. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.

The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, not on a new study providing specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter confirming regulatory clearance.

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The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

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I am sorry. I cannot answer your question. The document does not contain the information requested in your query. The document is an FDA 510(k) clearance letter for the "SPIFE LD Vis Isoenzyme Kit" and primarily discusses the regulatory approval, classification, and indications for use of the device. It does not provide details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.

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The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol are associated with atherosclerosis which leads to cardiovascular disease and strokes.

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These two pages contain a Food and Drug Administration (FDA) Substantial Equivalence Determination letter for the "Spife 2000/3000 Lipoprotein System" and an "Indications for Use" statement.

Unfortunately, this document does not contain the information requested regarding acceptance criteria, device performance tables, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

This letter is a regulatory approval document stating that the device is substantially equivalent to a previously marketed predicate device and can be marketed. It summarizes the regulatory classification and general controls but does not delve into the specific technical studies or performance data that led to that determination.

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Ask a specific question about this device