(71 days)
Not Found
Not Found
No
The description details a turbidimetric assay based on antibody-antigen binding and optical measurement, with no mention of AI or ML techniques.
No
The device is a diagnostic tool that measures protein/albumin levels in urine to aid in the diagnosis and treatment of diseases. It does not actively treat or intervene in a disease condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the identification of urinary protein or albumin (nonquantitative) using this device "is used in the diagnosis and treatment of disease conditions." This directly indicates its role as a diagnostic tool.
No
The device description clearly outlines a chemical reaction involving a sample, buffer, and antibody, followed by optical measurement of turbidity. This indicates a physical, hardware-based testing system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "test system" intended to "identify proteins or albumin in urine." It also states that this identification is "used in the diagnosis and treatment of disease conditions." This directly aligns with the definition of an IVD, which is a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details a method for detecting albumin in a sample (urine) using a chemical reaction (antigen-antibody binding) that produces a measurable result (turbidity). This is a typical process for an in vitro diagnostic test.
- Sample Type: The device analyzes a "urinary sample," which is a specimen derived from the human body.
The information provided clearly indicates that this device is designed to perform a test on a human biological sample outside of the body to provide information relevant to a patient's health status, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JIS; JIQ; JJX
Device Description
When a sample is mixed with Buffer and Antibody, albumin in the sample combines specificaaly with anti-human albumin antibody (goat) in the Antibody to yeild an insoluble aggregate that causes increases turbidity in the solution. The degree of the turbidity of solution can be measured optically and is proportional to the concentration of albumin in the patient's 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)
Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estamiated to be 0.33 ug/dL. In comparison studies against the prodicate, Wako Micro Albumin B assay, a correlation cocfficient of 0.9984 and a regression cquation of y = 1.0179x - 0.9619 was obtained.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.
0
APR 1 1 2003
Nako
Wako Diagnostics
1600 Bellwood Road, Richmond, VA 23237 U.S.A.
510(k) Summary of Safety and Effectiveness
Diabetic nephropathy, which is accompanied by irreversible kidney damage and persistent proteinuria, is a major cause of death in persons with insulin-dependent diabctes mellitus and a main reason to initiate hemodialysis. Therefore, detection of kidney (glomerular) damage that is minimal and reversible is important. Microalbuminuria is a condition characterized by increased urinary excretion of albumin in the absence of overt nephropathy. It has been reported in several sludies to predict development of diabetic nephropathy and its mortality risk in both diabetes mellitus of insulin-dependent and non-insulin-dependent.
Because micro-albuminuria may be reversible if diabctes is well controlled, its early detection may be very beneficial in treatment programs for diabetes.
Principle of the method
When a sample is mixed with Buffer and Antibody, albumin in the sample combines specificaaly with anti-human albumin antibody (goat) in the Antibody to yeild an insoluble aggregate that causes increases turbidity in the solution. The degree of the turbidity of solution can be measured optically and is proportional to the concentration of albumin in the patient's sample.
Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estamiated to be 0.33 ug/dL. In comparison studies against the prodicate, Wako Micro Albumin B assay, a correlation cocfficient of 0.9984 and a regression cquation of y = 1.0179x - 0.9619 was obtained.
TELEPHONE (877) 714-1924 FACSIMILE (804) 271-7791 E-MAIL diagnostics@wakousa.com WEBSITE www.wakousa.com
A division of Wako Chernicals USA, Inc
1
References:
Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 200 Ed., Sanuders, Philadelphia, 1994.
Lothar Thomas, M.D., Ed.: Clinical Laboratory Diagnostics DG Klinische Chemie Mitteilungen 26 (1995) page 5 Mount.J.N. : Journal of Clinical Pathology, 22, 12 (1986) Rosenstock, j. and Raskin, P .: Diabetes Care, 9, 529 (1986) Mogensen, Christensen, C.K. and Vittinghus, E .: Diabetes, 32 (Suppl.2), 64 (1983) Viberti, G.C. et al : Kidney International, 21, 714 (1982) Schmitz, A. and Vaeth, M. : Diabetic Medicine, 5, 126 (1988) Mogensen, C.E. et al : N.. Engl. J. Med., 311, 89 (1984) Mogensen, C.E.:N. Engl. J. Med., 310, 356 (1984)
Kuzellallory
Tonya Mallory, Executive Man
April 17, 2003
April 7, 2003 Wako Diagnostics Wako Chemicals USA, Inc. . 1600 Bellwood Road Richmond, VA 23237
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 1 2003
Ms. Lori Creasy Regulatory Affairs Specialist Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237
Re: K030320
Trade/Device Name: Wako Autokit Micro Albumin Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: Class II Product Code: JIS; JIQ; JJX Dated: January 29, 2003 Received: January 30, 2003
Dear Ms. Creasy:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 –
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use:
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Idetnification 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.
Proprietary Name: Wako Autokit Micro Albumin
Established Registration Number: 1627434
Premarket Notification 510 (k) Number:
(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 (Optional Format 1-2-96)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030320