(88 days)
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Not Found
No
The description details a turbidimetric immunoassay system that measures albumin concentration based on turbidity. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The mechanism described is a standard chemical reaction and optical measurement.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of albumin in human urine, which is a diagnostic function, not a therapeutic one. It provides information for screening, diagnosing, monitoring, and supplementing clinical evidence, but it does not treat or cure a disease.
Yes
The device is intended for "screening for, diagnosing, monitoring" microalbuminuria, which are all diagnostic purposes.
No
The device description explicitly states the system consists of an analyzer (hardware) and microcuvettes (hardware with reagents), and the process involves physical steps like filling the cuvette, inserting it into the analyzer, mixing, and measuring turbidity. This is a hardware-based system with software controlling the analysis and display.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro diagnostic use only" for the microcuvettes and describes the quantitative determination of albumin in human urine for screening, diagnosing, monitoring, and supplementing clinical evidence for microalbuminuria. This is a classic definition of an IVD.
- Device Description: The device analyzes a biological sample (urine) outside of the body to provide diagnostic information. The process involves chemical reactions within the microcuvette and measurement of turbidity, which are typical IVD methods.
- Anatomical Site: The sample is human urine, which is a biological specimen analyzed in vitro.
- Intended User / Care Setting: While used at the point-of-care, it is for "professional use only," indicating it's used by trained healthcare professionals for diagnostic purposes.
- Predicate Device: The mention of a predicate device (Clinitek 50 Urine Chemistry Analyzer) further supports its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
N/A
Intended Use / Indications for Use
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 analyzer. The system can be used specially decigitive determination of low levels of albumin in urine for the purpose of for the qualifically o osing, monitoring and to supplement the clinical evidence in the servening for, and grounds, aria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially The qualifilative, rapid, turblaiment inimanousedy of the system is designed be used for the designed system, the Homoodo Albemin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the or screening for, diagnosing montoning on testing using spot samples or timed treathern of microutburnmand. The Stained within 90 seconds. HemoCue Urine Albumin Collections: A quanticative roodic is obtained in the HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes.
Product codes (comma separated list FDA assigned to the subject device)
KQO, JIQ
Device Description
The Hemoouvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcavettes. The merces on one of the filled cuvette is inserted into urine sample is that in the the contents of the cuvette are mixed through the HomoCae Fribunan 2005, the immunochemical reaction is completed and the turbidity is vioration. Within 90 comment concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Studies were conducted in-house and in clinical settings to demonstrate the performance of Studies were conducted in noube and that the intended user can easily operate the system and obtain urinalysis results as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(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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053 253
| Submitter: | HemoCue AB
Box 1204
Angelholm, Sweden SE-262 23 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | +46 431 45 82 00 (Telephone)
+46 431 45 82 25 (FAX) |
| Contact: | Allan White (Official Correspondent)
HemoCue, Inc.
40 Empire Drive
Lake Forest, CA 92630-2244
(800) 881-1611 x110 (Telephone)
(949) 859-3066 (FAX)
allan@hemocue.com |
| Date of Preparation: | November 18, 2005 |
| Proprietary Name: | HemoCue Albumin 201 analyzing system |
| Classification Name: | Automated Urinalysis System |
| Common Name: | HemoCue Albumin 201 |
| Equivalent to: | Clinitek 50 Urine Chemistry Analyzer |
| Microcuvette: | Regulation Number = 862.1645
Product Code = JIQ
Classification = Class I exempt |
510(k) Summary 10.0
Description
Discription The Hemoouvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcavettes. The merces on one of the filled cuvette is inserted into urine sample is that in the the contents of the cuvette are mixed through the HomoCae Fribunan 2005, the immunochemical reaction is completed and the turbidity is vioration. Within 90 comment concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.
Intended Use
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a The qualifiative, fupic, the HemoCue Albumin 201 analyzer. The system can be used specially decigitive determination of low levels of albumin in urine for the purpose of for the qualifically o osing, monitoring and to supplement the clinical evidence in the servening for, and grounds, aria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine
1
Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.
Technological Characteristics
The HemoCue Albumin 201 assay employs an immunoassay for the microalbumin test. The The HemoCuc Alountin 201 about only the sample is drawn into the microcuvette by reagents are continued in the microcuvettes are inserted into the analyzer for measuring. Capillary force anter which the reaction steps and automatically performs The remocule Albumn 201 Thanyses Results are displayed on the instrument screen. The system is factory calibrated.
Assessment of Performance
Studies were conducted in-house and in clinical settings to demonstrate the performance of Studies were conducted in noube and that the intended user can easily operate the system and obtain urinalysis results as the predicate device.
Conclusion
The HemoCue Albumin 201 analyzing system is a convenient method for measuring The HelloCue > Abumin 201 and Jused by typical users and provide clinical results microunding in arme and ears of in current clinical laboratory and point-of-care practices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB 1 7 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HemoCue AB c/o Mr. Allan White HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630-2244
Re: K053253
Trade/Device Name: HemoCue Albumin 201 Analyzer Regulation Number: 21 CFR 862.2900 Regulation Name: Automated Urinalysis System Regulatory Class: Class I Product Code: KQO, JIQ Dated: January 25, 2006 Received: January 26, 2006
Dear Mr. White
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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your le FDA finding of substantial equivalence of your device to a legally premarket notification. "The PDs 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, rr you don't opportive mostion and advertising of your device, please contact the Office of In of questions on the promostic Device Evaluation and Safety at (240) 276-0484. Also, please note the vitro Diagnetitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of amall 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/industry/support/index.html.
Sincerely vours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOS 3253
Device Name: __ HemoCue Albumin 201 analyzer
Indications For Use:
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially The qualifilative, rapid, turblaiment inimanousedy of the system is designed be used for the designed system, the Homoodo Albemin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the or screening for, diagnosing montoning on testing using spot samples or timed treathern of microutburnmand. The Stained within 90 seconds. HemoCue Urine Albumin Collections: A quanticative roodic is obtained in the HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
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