(56 days)
Not Found
No
The device is a control material for verifying the precision and accuracy of existing systems, not a system that performs analysis or interpretation using AI/ML. The description focuses on the composition and packaging of the control material.
No
This device is an assayed albumin control used to verify the precision and accuracy of urine albumin systems, not to directly treat a medical condition.
No
The device is an assayed albumin control intended for professional use in the verification of the precision and accuracy of other diagnostic systems (HemoCue® Urine Albumin and HemoCue® Albumin 201 systems), rather than for diagnosing a condition itself.
No
The device description clearly states that AlbuTrol is a physical control material (human urine with albumin) packaged in dropper bottles, which are hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic devices that measure a substance in a biological sample (urine).
- Device Description: It's described as an "assayed urine albumin control material" containing "human urine with a specific amount of human albumin." This is a classic description of a control material used in laboratory testing.
- Professional Use: It's intended for "professional use," which aligns with the typical use of IVD controls in clinical or laboratory settings.
- Predicate Device: The mention of a predicate device (K023928; MAS® UA Control) which is also a control material, further supports its classification as an IVD.
Control materials like AlbuTrol are essential components of the quality control process for IVD tests, ensuring the reliability and accuracy of the results.
N/A
Intended Use / Indications for Use
AlbuTrol is an assayed albumin control intended for professional use in the verfication of the precision and accuracy of the HemoCue Urine Albumin as in the Venceausn' of the United 201 system. On these systems, AlbuTrol performs in the same way as human urine does. AlbuTrol is for in vitro use only. AlbuTrol is for professional o way us .
Product codes
JJX
Device Description
AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Each dropper bottle contains 1.0 mL human urine with a specific amount of human albumin. AlbuTrol provides two physiologically relevant levels covering the clincally interesting ranges of urine albumin: ~25 mg/L albumin and ~75 mg/L aboumin. The assigned values of each batch are printed on both the carton box and the dropper bottles.
AlbuTrol is packed in carton boxes. Each carton box contains 2 dropper bottles of the same level on a carton tray. An insert with Intended Use is packed in each box of album of the
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
professional use
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 to demonstrate the performance on the HemoCue Urine Albumin system and the HemoCue Albumin 201 analyzing system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K 060 2/5
510(k) Summarv
| Submitter: | Eurotrol B.V.
Keplerlaan 20
6716 BS Ede, The Netherlands |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | +31 318 695777 (Telephone)
+31 318 695770 (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: | January 18, 2006 |
| Proprietary Name: | AlbuTrol Low and AlbuTrol High |
| Classification Name: | Quality control material (assayed and unassayed) (21 CFR
862.1660, Product Code JJX) |
| Common Name: | AlbuTrol |
| Equivalent to: | MAS® UA Control, 510(k) document control number K023928 |
Description
AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Each dropper bottle contains 1.0 mL human urine with a specific amount of human albumin. AlbuTrol provides two physiologically relevant levels covering the clincally interesting ranges of urine albumin: ~25 mg/L albumin and ~75 mg/L aboumin. The assigned values of each batch are printed on both the carton box and the dropper bottles.
AlbuTrol is packed in carton boxes. Each carton box contains 2 dropper bottles of the same level on a carton tray. An insert with Intended Use is packed in each box of album of the
Intended Use
AlbuTrol is an assayed albumin control intended for professional use in the verfication of the precision and accuracy of the HemoCue Urine Albumin as in the Venceausn' of the United 201 system. On these systems, AlbuTrol performs in the same way as human urine does. AlbuTrol is for in vitro use only. AlbuTrol is for professional o way us .
Technological Characteristics
AlbuTrol is filled in 3 mL dropper bottles made of Low Density Polyethylene. Each dropper bottle is capped with a dropper tip and a colored cap, both made of polypropylene.
1
Values of AlbuTrol are assigned on factory calibrated HemoCue Albumin 201 systems. The stability of AlbuTrol is 9 months from value assignment.
To obtain a drop of control material the dropper bottle needs to be pressed slightly. After dispense of a drop of the control material onto a hydrophobic surface, for example a plastic film, the sample is drawn into the microcuvette by capillary force. After that the microcuvettes need to be inserted into the system for measuring immediately.
Assessment of Performance
Studies were conducted in-house to demonstrate the performance on the HemoCue Urine Albumin system and the HemoCue Albumin 201 analyzing system.
Conclusion
The AlbuTrol control materials are convenient control materials for professional use in the verfication of the precision and accuracy of the HemoCue Urine Albumin system and the HemoCue Albumin 201 system.
2
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 features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 4 2006
EuroTrol B.V. c/o Mr. Allan White Quality Systems Manager HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630
Re: K060215
Trade/Device Name: AlbuTrol Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 15, 2006 Received: March 16, 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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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 (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 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
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
4
Indications for Use
510(k) Number (if known): K060215
Device Name: AlbuTrol
Indications For Use:
AlbuTrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OVD)
Vision Sign-Off
Office of *In Vitro Diagnostic Device
Evaluation and Safety
K060215
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