(22 days)
Not Found
Not Found
No
The provided text describes a simple in vitro diagnostic test for urinary albumin and does not mention any AI or ML components.
No
The device is for in vitro diagnostic use, meaning it's used to detect or diagnose conditions (like early kidney disease), not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "For IN VITRO diagnostic use" and describes the test's purpose in detecting conditions like kidney disease.
No
The intended use describes an in vitro diagnostic test that measures albumin levels in urine, which strongly suggests a physical test kit or device is involved, not just software. The lack of a device description further supports this interpretation.
Yes, this device is an IVD (In Vitro Diagnostic).
The very first line of the "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use."
This statement, along with the description of the test's purpose (determining albumin levels in urine to help detect and treat patients at risk for renal disease), clearly indicates that the device is intended for use outside of the body to diagnose a condition.
N/A
Intended Use / Indications for Use
For IN VITRO diagnostic use.
There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L.
Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8): hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).
Product codes
JIR
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2002
Mr. Mike Berg Diagnostic Chemicals Limited 2637 Eva Street Laguna Hills, CA 92656
K022538 Re: Trade/Device Name: ImmunoDip™ Urinary Albumin Test Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: Class I Product Code: JIR Dated: July 30, 2002 Received: August 1, 2002
Dear Mr. Berg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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
2
| 510(k) Number (if known): | K022538
and and and the commend of the first and the first and the first and the many of the may be any and the may be any and
Comments of Children Andrews of the Art Advanced Annual Comments |
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
ImmunoDip™ Urinary Albumin Tost Device Name:
Indications for Use:
For IN VITRO diagnostic use.
There are several kidney disease conditions that can produce high levels of albumin in urine (1). Deternining alburnin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but clevated urinary albumin levels, or microalbuminuria, refers to a level of the human protcin albumin in urine above about 18 mg/L . Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifics samples as positive based on their boing above or below a level of 18 mg/L.
Conditions in which clovated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8): hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urinc hclps to identify those diabetics who are prone to kidney disease. Scientific studics indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use
Alberto Sinto for
(Division Sign-Off)
ivision Sion-Off Division of Clinical 510(k) Number
Tear Cooper