(74 days)
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No
The summary describes a reagent for an immunochemistry system and does not mention any AI or ML components. The performance studies focus on standard analytical chemistry metrics like method comparison, stability, and imprecision.
No.
This device is an in-vitro diagnostic reagent used for the quantitative determination of human alpha-macroglobulin, which aids in the diagnosis of blood-clotting or clot lysis disorders. It does not directly treat or alleviate a disease or condition.
Yes
The device is described as aiding in the "diagnosis of blood-clotting or clot lysis disorders," indicating its use in identifying or characterizing a medical condition.
No
The device is a reagent intended for use with a specific hardware system (Beckman IMMAGE Immunochemistry Systems). It is an in vitro diagnostic product, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human alpha~ macroglobulin by rate nephelometry" and that this measurement "may aid in the diagnosis of blood-clotting or clot lysis disorders." This clearly indicates it's used to analyze a sample taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description reinforces that it's a reagent used for "quantitative determination of Alpha-Macroglobulin concentrations" on an immunochemistry system.
- Input Imaging Modality: It's listed as "Not Applicable (In vitro diagnostic reagent)," further confirming its nature as a reagent used in laboratory testing.
- Anatomical Site: It's listed as "Not Applicable (In vitro diagnostic reagent)," as the test is performed on a sample outside the body.
- Predicate Device: The predicate device listed is also an Alpha₂-Macroglobulin (AMG) test system, which are typically IVDs.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry.
Clinical Significance:
Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
Product codes (comma separated list FDA assigned to the subject device)
DEB
Device Description
The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained on the IMMAGE System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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