(24 days)
K81194
Not Found
No
The description details a standard clinical chemistry assay based on a chemical reaction and absorbance measurement, with no mention of AI or ML.
No
The device is described as an in vitro diagnostic assay used for the quantitative determination of albumin in human serum or plasma, which aids in the diagnosis and treatment of diseases, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "used in the diagnosis and treatment of numerous diseases". Also, the "Device Description" identifies it as an "in vitro diagnostic assay".
No
The device is an in vitro diagnostic assay, which is a chemical test performed on biological samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitation of albumin in serum and plasma" and that these measurements are "used in the diagnosis and treatment of numerous diseases." This clearly indicates a diagnostic purpose using biological samples.
- Device Description: The description further clarifies that it is an "in vitro diagnostic assay" for the "quantitative determination of albumin in human serum or plasma." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body.
- Performance Studies: The performance studies describe testing the assay's performance using control material and comparing it to a predicate device, which is typical for validating an IVD.
- Predicate Device: The mention of a predicate device (K81194; Boehringer Mannheim® Albumin BCG assay on the Hitachi® 717 Analyzer) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence for IVD submissions.
All these points collectively confirm that the Albumin BCG assay is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Albumin BCG assay is used for the quantitation of albumin in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Product codes (comma separated list FDA assigned to the subject device)
75CIX
Device Description
Albumin BCG is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCG assay is a clinical chemistry assay in which the analyte in the sample binds specifically to bromcresol green to produce a colored complex. The absorbance at 628 nm of the complex is directly proportional to the albumin concentration in the sample.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET™ System. The Albumin BCG assay method comparison yielded acceptable correlation with the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9935, slope = 0.893, and Y-intercept = 0.643 g/dL. Precision studies were conducted using the Albumin BCG assay. Within-run, between-run, and between day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.9%. The Albumin BCG assay is linear up to 11.8 g/dL. The limit of quantitation (sensitivity) of the Albumin BCG assay is 0.2 g/dL. These data demonstrate that the performance of the Albumin BCG assay is substantially equivalent to the performance of the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9935, slope = 0.893, and Y-intercept = 0.643 g/dL. The total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.9%. The Albumin BCG assay is linear up to 11.8 g/dL. The limit of quantitation (sensitivity) of the Albumin BCG assay is 0.2 g/dL.
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.
K81194
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.
Not Found
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).
Not Found
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
K981758
510(k) Summary
Submitter's name/address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
JUN | 2 1998
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 18, 1998 |
|---|---|
| Device Trade or Proprietary Name: | AlbG |
| Device Common/Usual Name or Classification Name: | Albumin BCG |
| Classification Number/Class: | 75CIX/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Test Description:
Albumin BCG is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCG assay is a clinical chemistry assay in which the analyte in the sample binds specifically to bromcresol green to produce a colored complex. The absorbance at 628 nm of the complex is directly proportional to the albumin concentration in the sample.
Substantial Equivalence:
The Albumin BCG assay is substantially equivalent to the Boehringer Mannheim® Albumin BCG assay (K81194) on the Hitachi® 717 Analyzer.
This assay yields similar Performance Characteristics.
Albumin BCG 510/k) May 18, 1998 Aero ALBGf.lwp
Section II Page 1
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Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of albumin. .
- Both assays yield similar clinical results. .
Intended Use:
The Albumin BCG assay is used for the quantitation of albumin in human serum and plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Albumin BCG assay method comparison yielded acceptable correlation with the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9935, slope = 0.893, and Y-intercept = 0.643 g/dL. Precision studies were conducted using the Albumin BCG assay. Within-run, between-run, and between day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.9%. The Albumin BCG assay is linear up to 11.8 g/dL. The limit of quantitation (sensitivity) of the Albumin BCG assay is 0.2 g/dL. These data demonstrate that the performance of the Albumin BCG assay is substantially equivalent to the performance of the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer.
Conclusion:
The Albumin BCG assay is substantially equivalent to the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Albumin BCG 510(k) May 18, 1998 Aero ALBGf.lwp
Section II Page 2
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines forming the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 2 1998
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas
K981758 Re : Albumin BCG Requlatory Class: II Product Code: CIX Dated: May 18, 1998 Received: May 19, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The qeneral controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally . marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ Albumin BCG
Indications For Use:
i
The Albumin BCG assay is used for the quantitation of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981758
11 20000000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR V (Per 21 CFR 801.109) (Optional Format 1-2-96)