(56 days)
Not Found
Not Found
No
The summary describes a standard immunoturbidimetric assay for measuring albumin in urine, which is a well-established laboratory technique that does not typically involve AI or ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as being for "IN VITRO diagnostic use" and determines levels of albumin in urine, which are characteristics of a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states, "For IN VITRO diagnostic use," explicitly identifying it as a diagnostic device.
No
The device description clearly states it uses an "immunoturbidimetric format," which is a laboratory assay method involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use." This is the key indicator that the device is intended for use outside of the body to diagnose or detect a condition.
N/A
Intended Use / Indications for Use
For the quantitative determination of low levels of albumin in urine.
For IN VITRO diagnostic use.
Low levels of protein are normally excreted in the of healthy individuals. The uriniferous tubules and glomentifiter out m of these excreted mucoproteins. Albumin, a protein of molecular weight of 50,000, is not easily filtered out and small .1s are excreted into the urine. Increased excretion of albuminuria) is an early indicator of glomerular aı. disease (1,2).
Microalbuminuria is characterized by increased urinary excretion of albumin in the absence of overt nephropathy (3,4). Microalbumin is recognized as a strong predictor of impending nephropathy in Type I Diabetics and its mortality risk in diabetic patients (5). Early detection of microalbuminuria may be beneficial for treatment programs for diabetics because renal damage may be reversible if diabetes is well controlled at this stage.
Many of the methods traditionally used for measuring albumin lack the sensitivity and precision required for measuring microalbumin. The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.
Product codes
DCF
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
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.
JUL 5 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Penny J. White Regulatory Affairs, Coordinator, External Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE CIA 2E6
K051191 Re:
Trade/Device Name: Microalbumin Assay Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: May 5, 2005 Received: May 10, 2005
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your 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).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will anon " you we cognifinding of substantial equivalence of your device to a legally prematicated 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 or questions on the promie Evaluation and Safety at (240) 276-0484. 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 Tou may other built beatherers, 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(K) Notification
Diagnostic Chemicals Limited
Microalbumin Assay, Cat. No. 252-2
Image /page/2/Picture/3 description: The image shows a stylized logo or symbol, possibly representing a brand or organization. The design consists of interconnected, blocky shapes that form what appear to be abstract letters or characters. The overall impression is modern and geometric, with a bold, black-and-white color scheme that emphasizes the shapes and lines of the design. The logo has a unique and memorable appearance.
INDICATIONS FOR USE
510(k) Number (if known):
K05119.1.
Device Name:
Microalbumin Assay
Indications for Use:
For the quantitative determination of low levels of albumin in urine.
For IN VITRO diagnostic use.
Low levels of protein are normally excreted in the of healthy individuals. The uriniferous tubules and glomentifiter out m of these excreted mucoproteins. Albumin, a protein of molecular weight of 50,000, is not easily filtered out and small .1s are excreted into the urine. Increased excretion of albuminuria) is an early indicator of glomerular aı. disease (1,2).
Microalbuminuria is characterized by increased urinary excretion of albumin in the absence of overt nephropathy (3,4). Microalbumin is recognized as a strong predictor of impending nephropathy in Type I Diabetics and its mortality risk in diabetic patients (5). Early detection of microalbuminuria may be beneficial for treatment programs for diabetics because renal damage may be reversible if diabetes is well controlled at this stage.
Many of the methods traditionally used for measuring albumin lack the sensitivity and precision required for measuring microalbumin. The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.
Prescription Use ---------V
AND/OR
Over the Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (IVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Kos1191 510(k) __