(73 days)
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No
The summary describes a traditional in vitro diagnostic reagent and nephelometry system, which relies on light scattering and comparison to a standard, not AI/ML algorithms. There are no mentions of AI, ML, or related concepts.
No.
The device is described as an in vitro diagnostic reagent used to measure albumin, which aids in the diagnosis of diseases, rather than directly treating or preventing them.
Yes
The 'Intended Use' section clearly states that the device is "used as an aid in the diagnosis of kidney and intestinal diseases."
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device. It is used in conjunction with a Behring Nephelometer System, which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the device is an "in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases." This clearly indicates its use for diagnostic purposes outside of the living body.
- Device Description: The description details how the device works by reacting with components in human samples (serum, cerebrospinal fluid, and urine) to form immune complexes, which are then measured. This process is characteristic of in vitro diagnostic tests.
- Nature of the Test: The device measures the concentration of albumin in biological fluids. Measuring specific substances in bodily fluids to aid in diagnosis is a core function of IVDs.
N/A
Intended Use / Indications for Use
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.
Product codes
DCF
Device Description
The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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
Correlation: Comparative studies to measure albumin in urine using N Antiserum to Human Albumin and Beckman micro Albumin (MA) Reagent were conducted. In 79 urine samples, ranging from 11.51 to 5259.42 mg/L, the correlation coefficient was 0.99, the yintercept was -0.73 and the slope was 1.12.
Precision: The N Antiserum to Human Albumin was evaluated for the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.21 to 3.94, and inter-assay precision %CV ranged from 1.77 to 5.01.
Key Metrics
Correlation coefficient: 0.99
yintercept: -0.73
slope: 1.12
Intra-assay precision %CV: 2.21 to 3.94
Inter-assay precision %CV: 1.77 to 5.01
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5040 Albumin immunological test system.
(a)
Identification. 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.(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 § 866.9.
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Behring Diagnostics Inc. N Antiserum to Human Albumin 510(k) Notification
OCT 20 1997
510(k) SUMMARY FOR N ANTISERUM TO HUMAN ALBUMIN
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacture
Behringwerke GmBH Postfach 1140 35001 Marburg Germany
| Distributor | Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617-320-3000 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Ruth Forstadt |
| Date of Preparation: | July 7, 1997 |
Name/ Classification: 2 . Device
N Antiserum to Human Albumin
FDA has classified N Antiserum to Human Albumin into Class II (866.5040).
3 . Identification of the legally marketed device:
Beckman micro Albumin(MA) Reagent -K895883
Proposed Device Description: 4 .
The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
5 . Proposed Device Intended Use:
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, csf and urine, used as an aid in the diagnosis of kidney and intestinal diseases.
1
Behring Diagnostics Inc. N Antiserum to Human Albumin 510(k) Notification
Medical device to which equivalence is claimed and comparison 6. information.
The N Antiserum to Human Albumin is substantially equivalent in intended use and results to the Beckman micro Albumin (MA) Reagent, in that both methods measure human albumin in urine.
Proposed Device Performance Characteristics: 7 .
Correlation:
Comparative studies to measure albumin in urine using N Antiserum to Human Albumin and Beckman micro Albumin (MA) Reagent were conducted. In 79 urine samples, ranging from 11.51 to 5259.42 mg/L, the correlation coefficient was 0.99, the yintercept was -0.73 and the slope was 1.12.
Precision:
The N Antiserum to Human Albumin was evaluated for the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.21 to 3.94, and inter-assay precision %CV ranged from 1.77 to 5.01.
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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 top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Ruth Forstadt Requlatory Affairs Associate Behring Diagnostics, Inc. 151 University Avenue Westwood, Massachusetts 02090
OCT 20 1997
Re : K972929 Trade Name: N Antiserum to Human Albumin Regulatory Class : II Product Code: DCF Dated: August 7, 1997 Received: Auqust 8, 1997
Dear Ms. Forstadt:
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 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 requirement, 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
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Behring Diagnostics Inc. . N Antiserum to Human Albumin 510(k) Notification
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510(k) Number (if known): K972929
Device Name:_
N Antiserum to Human Albumin
Indications For Use:
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum. cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Meglem
0 D U SUCNB IS 5 31.0. 11. 211. 211. 2
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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