(150 days)
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No
The summary describes a reagent for a standard immunochemistry system using rate nephelometry, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic reagent used for quantitative determination of a human protein, not for treating or preventing disease.
Yes
The device is intended for the "quantitative determination of human alpha-acid glycoprotein by rate nephelometry" in human serum samples. This measurement of a biological marker to provide quantitative results is a diagnostic function.
No
The device is a reagent kit used with an immunochemistry system, which are physical components, not software.
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-acid glycoprotein by rate nephelometry." This is a laboratory test performed on biological samples (human serum).
- Device Description: The description confirms it's used for "quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples." Again, this points to a laboratory test on biological material.
- Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (Beckman Alpha₁-Acid Glycoprotein Reagent) with a K number (K791341) indicates that this device is being compared to a previously cleared IVD.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.
Product codes
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Device Description
The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples 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
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 from the Beckman Reagents to the IMMAGE System Reagents.
Method Comparison Study Results IMMAGE Alpha-1-Acid Glycoprotein (AAG) Reagent:
Analyte: IMMAGE AAG Reagent, Sample Type: serum, Slope: 0.954, Intercept: 1.62, r: 0.994, n: 141, Predicate Method: Beckman AAG Reagent on Array® 360
Stability Study Results:
Reagent: IMMAGE AAG, Product Claim: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only
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§ 866.5420
Alpha -1-glycoproteins immunological test system.(a)
Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent
1.0 Submitted By:
MAR 2 4 1997
Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
24 October 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent
3.2 Classification Name
1
Alpha-1-glycoproteins immunological test system (21 CFR § 866.5420)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|----------------------------------------------------|---------------------------------------------|------------------------------|------------------|
| IMMAGE System
Alpha₁-Acid
Glycoprotein (AAG) | Beckman Alpha₁-Acid
Glycoprotein Reagent | Beckman Instruments,
Inc. | K791341 |
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent Summary of Safety & Effectiveness
5.0 Description:
The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| IMMAGE System | ||
| AAG Reagent | Initial Analytic Range | Same as |
| Beckman AAG Reagent | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| AAG Reagent | Buffer/Reagent volumes | IMMAGE System uses half of |
| the volumes than are utilized | ||
| by the Array System for AAG. | ||
| Antibody concentration | IMMAGE AAG has a higher | |
| antibody concentration than | ||
| the Beckman Alpha₁-Acid | ||
| Glycoprotein reagent. |
2
8.0 Summary of Performance Data:
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 from the Beckman Reagents to the IMMAGE System Reagents.
Method Comparison Study Results IMMAGE Alpha-1-Acid Glycoprotein (AAG) Reagent
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| AAG | ||||||
| Reagent | serum | 0.954 | 1.62 | 0.994 | 141 | Beckman AAG Reagent |
| on Array® 360 |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE AAG | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Within-Run Imprecision
|
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This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.