(149 days)
Not Found
No
The summary describes a reagent and system for quantitative determination of a substance using rate nephelometry, a standard laboratory technique. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a reagent and system for the quantitative determination of human alpha-antitrypsin, which is a diagnostic function rather than a therapeutic one.
Yes
The device is intended for the quantitative determination of human alpha-antitrypsin, which is a measurement used in diagnosing conditions.
No
The device description clearly states it is a "Reagent" and is used in conjunction with a "System," indicating it is a chemical substance and part of a larger hardware system, not software only.
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-antitrypsin by rate nephelometry" using human serum samples. This is a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces that it's for "quantitative determination of alpha-antitrypsin concentrations in human serum samples."
- Performance Studies: The performance studies compare the results obtained from this reagent on the IMMAGE System to a predicate device (K771603; Beckman Alpha₁-Antitrypsin (AAT)), which is also an IVD. This comparison is typical for demonstrating substantial equivalence for IVDs.
The core function of the device is to analyze a biological sample (human serum) outside of the body to provide information about a patient's health status (alpha-antitrypsin levels), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Alpha-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-antitrypsin by rate nephelometry.
Product codes
Not Found
Device Description
The IMMAGE Immunochemistry System AAT Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of alpha-antitrypsin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results IMMAGE Alpha -- Antitrypsin (AAT) Reagent
| MMAS | Sentifi AN OFFICE CLASS CHARA COUNTS COLLEGIAL COLLECTION CALL | LA MARK LEW LE LED LEBELLER FREE BUILDE | BECKHall Alla Systems AAT |
|---|
Stability Study Results
| Production of the seems that the first the count of the collection who . азаманаларнанавания иманича в качата в авина седельно време в однаставия обща. « два и винания» . | Comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of th WARENALES A F L L P P P R B B B R B R W S . L . L . L . L . L |
|---|---|
| 14 day open container stability | |
| A S CONSULER OF C ON CONSULENCE LIEF FEE BE B LEE |
Imprecision Study Results:
| TYPE OF PRECISION | SAMPLE | Data Points | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
|---|---|---|---|---|---|
| Within Run | Serum Level 1 | 80 | 70.1 | 1.87 | 2.7 |
| Serum Level 2 | 80 | 296 | 6.2 | 2.1 | |
| Serum Level 3 | 80 | 509 | 15.9 | 3.1 | |
| Total | Serum Level 1 | 80 | 70.1 | 2.33 | 3.3 |
| Serum Level 2 | 80 | 296 | 8.2 | 2.8 | |
| Serum Level 3 | 80 | 509 | 16.4 | 3.2 |
| TYPE OF PRECISION | SAMPLE | Data Points* | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
|---|---|---|---|---|---|
| Within Run | Low Serum Level 1 | 30 | 10.9 | 0.36 | 3.3 |
| Low Serum Level 2 | 30 | 44.3 | 0.72 | 1.6 | |
| Total | Low Serum Level 1 | 30 | 10.9 | 0.40 | 3.7 |
| Low Serum Level 2 | 30 | 44.3 | 0.73 | 1.6 |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).
0
BECKMAN
K9647Xdo.
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent
1
APR
1.0 Submitted By:
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
Date Submitted: 2.0
26 November 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent
3.2 Classification Name
Alpha-1-antitrypsin immunological test system. (21 CFR § 866.5130)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|-------------------------------------------|--------------------------------------|------------------------------|------------------|
| IMMAGE System
Alpha₁-Antitrypsin (AAT) | Beckman Alpha₁-
Antitrypsin (AAT) | Beckman Instruments,
Inc. | K771603 |
5.0 Description:
The IMMAGE Immunochemistry System AAT Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of alpha-antitrypsin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
Beckman Instruments, Inc.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent Summary of Safety & Effectiveness
6.0 Intended Use:
The IMMAGE Immunochemistry System Alpha-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-antitrypsin 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 | ||
| AAT Reagent | Analytic Range | Same as Beckman |
| Alpha₁-Antitrypsin reagent | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| AAT Reagent | Buffer/Reagent volumes | IMMAGE System uses half of |
| the volumes than are utilized | ||
| by the Array System for AAT. | ||
| Antibody concentration | IMMAGE AAT has a higher | |
| antibody concentration than | ||
| the Beckman Alpha₁- | ||
| Antitrypsin reagent |
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 results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results IMMAGE Alpha -- Antitrypsin (AAT) Reagent
|
.
.
|
|
CONSULERS
| |
.
|
иинавинание корича и прика в присанда в сериансия как как и селение как и в серия на комп
инининаниевааринина Аракистрания и седание насические продавиния |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MMAS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Sentifi
AN OFFICE CLASS CHARA COUNTS COLLEGIAL COLLECTION CALL
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | LA MARK LEW LE LED LEBELLER FREE BUILDE | | BECKHall Alla
Systems AAT |
2
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha--Antitrypsin (AAT) Reagent Summary of Safety & Effectiveness
.
Stability Study Results
| Production of the seems that the first the count of the collection who
.
азаманаларнанавания иманича в качата в авина седельно време в однаставия обща. « два и винания»
. |
Comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of th
WARENALES A F L L P P P R B B B R B R W S . L . L . L . L . L |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | 14 day open container stability |
| | A S CONSULER OF C ON CONSULENCE LIEF FEE BE B LEE |
| TYPE OF PRECISION | SAMPLE | Data Points | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
|---|---|---|---|---|---|
| Within Run | Serum Level 1 | 80 | 70.1 | 1.87 | 2.7 |
| Serum Level 2 | 80 | 296 | 6.2 | 2.1 | |
| Serum Level 3 | 80 | 509 | 15.9 | 3.1 | |
| Total | Serum Level 1 | 80 | 70.1 | 2.33 | 3.3 |
| Serum Level 2 | 80 | 296 | 8.2 | 2.8 | |
| Serum Level 3 | 80 | 509 | 16.4 | 3.2 |
Estimated Imprecision .
| TYPE
OF
PRECISION | SAMPLE | Data
Points* | Test
Mean
Value
(mg/dL) | SD
(mg/dL) | % CV |
|-------------------------|-------------------|-----------------|----------------------------------|---------------|------|
| Within Run | Low Serum Level 1 | 30 | 10.9 | 0.36 | 3.3 |
| | Low Serum Level 2 | 30 | 44.3 | 0.72 | 1.6 |
| Total | Low Serum Level 1 | 30 | 10.9 | 0.40 | 3.7 |
| | Low Serum Level 2 | 30 | 44.3 | 0.73 | 1.6 |
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.
్