(94 days)
Not Found
No
The device description and performance studies focus on a standard in vitro diagnostic assay based on immunological reactions and turbidity measurements. There is no mention of AI, ML, or related concepts.
No
This device is an in vitro diagnostic assay used for the quantitative determination of low levels of albumin in human urine to aid in the diagnosis of kidney and intestinal diseases. It does not provide therapy.
Yes
The intended use explicitly states, "Measurement of albumin aids in the diagnosis of kidney and intestinal diseases."
No
The device is an in vitro diagnostic assay, which involves reagents and a measurement system (implied by the turbidity measurement at specific wavelengths), indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is "used for the quantitation of low levels of albumin in human urine" and that it "aids in the diagnosis of kidney and intestinal diseases." This clearly indicates a diagnostic purpose performed on a sample taken from the human body.
- Device Description: The description further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine." The mechanism described (immunological test system, measuring turbidity) is consistent with in vitro diagnostic methods.
- Anatomical Site: The sample is "human urine," which is a biological specimen taken from the human body.
- Input Imaging Modality: It is listed as "Not Applicable (In vitro diagnostic assay)," which is a common characteristic of IVDs that don't rely on medical imaging.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Product codes
JIR
Device Description
Microalbumin is an in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine. Antibodies to albumin combine with albumin in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 340 and 700 nm, is directly proportional to the concentration of microalbumin in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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
Comparative performance studies were conducted using the AEROSET™ System. The Microalbumin assay method comparison yielded acceptable correlation with the K-ASSAY Microalbumin on the Hitachi 717 Analyzer. The correlation coefficient = 0.9985, slope = 1.032, and Y-intercept = - 0.132 mg/dL. Precision studies were conducted using the Microalbumin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 201 is 6.4% and Level 2/Panel 202 is 3.8%. The Microalbumin assay range is 0.441 to 30.86 mg/dL. The limit of quantitation (sensitivity) for the Microalbumin assay is 0.441 mg/dL. These data demonstrate that the performance of the Microalbumin assay is substantially equivalent to the performance of the K-ASSAY Microalbumin on the Hitachi 717 Analyzer.
Key Metrics
correlation coefficient = 0.9985, slope = 1.032, Y-intercept = - 0.132 mg/dL, total %CV for Level 1/Panel 201 is 6.4% and Level 2/Panel 202 is 3.8%, assay range is 0.441 to 30.86 mg/dL, limit of quantitation (sensitivity) is 0.441 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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 § 862.9.
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510(k) Summary
| Submitter's Name/Address | Contact Person |
|---|---|
| Abbott Laboratories | Linda Morris |
| 1920 Hurd Drive | Senior Regulatory Specialist MS 1-8 |
| Irving, Texas 75038 | Regulatory Affairs |
| (972) 518-6711 | |
| Fax (972) 753-3367 |
| Date of Preparation of this Summary: | October 23, 1998 |
|---|---|
| Device Trade or Proprietary Name: | µAlb |
| Device Common/Usual Name or Classification Name: | Microalbumin |
| Classification Number/Class: | 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: K1833344
Test Description:
Microalbumin is an in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine. Antibodies to albumin combine with albumin in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 340 and 700 nm, is directly proportional to the concentration of microalbumin in the sample.
Substantial Equivalence:
The Microalbumin assay is substantially equivalent to the K-ASSAY® Microalbumin (K934146) on the Hitachi® 717 Analyzer.
Microalbumin 510(k) October 23, 1998 MAib.lwp
Section II Page 1
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Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassay methods. .
- Both assays can be used for the quantitative determination of microalbumin. .
- Both assays yield similar clinical results. .
- Both assays are based on the formation of immune complexes. .
Differences:
- There is a difference between the assay range. .
Intended Use:
The Microalbumin assay is used for the quantitation of low levels of albumin in human urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Microalbumin assay method comparison yielded acceptable correlation with the K-ASSAY Microalbumin on the Hitachi 717 Analyzer. The correlation coefficient = 0.9985, slope = 1.032, and Y-intercept = - 0.132 mg/dL. Precision studies were conducted using the Microalbumin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 201 is 6.4% and Level 2/Panel 202 is 3.8%. The Microalbumin assay range is 0.441 to 30.86 mg/dL. The limit of quantitation (sensitivity) for the Microalbumin assay is 0.441 mg/dL. These data demonstrate that the performance of the Microalbumin assay is substantially equivalent to the performance of the K-ASSAY Microalbumin on the Hitachi 717 Analyzer.
Microalbumin 510(k) October 23, 1998 MAlb.lwp
Section II Page 2
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Conclusion:
The Microalbumin assay is substantially equivalent to the K-ASSAY Microalbumin on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Microalbumin 510(k)
October 23, 1998 MAlb.lwp
Section II
Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
JAN 28 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re: K983774 Trade Name: uAlb Regulatory Class: I Product Code: JIR Dated: January 6, 1999 Received: January 11, 1999
Dear Ms. Morris:
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 legally marketed predicate 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Regulation (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/dsma/dsmamain.html".
Sincerely yours.
Steven Sutman
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
5
510(k) Number (if known): ≤ 983774
Microalbumin -----Device Name:
Indications For Use:
The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Stan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 983774
(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 OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)