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.

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

AI/ML Overview

The provided text describes the 510(k) summary for AlbuTrol, a quality control material. It focuses on the product's description, intended use, technological characteristics, and a brief statement about performance assessment.

However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

Explicit acceptance criteria: The document states that AlbuTrol is for "verification of the precision and accuracy" of HemoCue systems, but it does not specify quantitative targets or thresholds for this precision and accuracy (e.g., a specific coefficient of variation, bias limits, etc.).
Detailed study methodology: It mentions "Studies were conducted in-house to demonstrate the performance," but provides no details about these studies, such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
Reported device performance: While it assures performance, it doesn't present actual results against any criteria.
Information on training sets, MRMC studies, or standalone performance.

Therefore, I cannot populate most of your requested tables and sections based solely on the provided text.

Here's an attempt to answer based on the limited information available, with significant gaps noted:

Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria or detailed reported performance values. It only generically states the material's purpose is for "verification of the precision and accuracy."

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Precision	(e.g., %CV < X, based on manufacturer's claims or industry standards for QC materials)	(No specific performance data provided)
Accuracy	(e.g., Bias < Y%, or within Z% of assigned value)	(No specific performance data provided)
Stability	9 months (as stated for AlbuTrol)	AlbuTrol is stated to have a 9-month stability.

Study Details

Due to the lack of detailed study information in the provided 510(k) summary, much of this section will be marked as "Not provided" or "Not applicable."

Sample size used for the test set and the data provenance:
- Sample size: Not provided. The document only states "Studies were conducted in-house."
- Data provenance: "In-house," implying data generated by Eurotrol B.V. or HemoCue. Retrospective/Prospective status is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. For quality control materials like AlbuTrol, ground truth (assigned values) is typically established by the manufacturer using calibrated reference methods on in-house instruments. The document states: "Values of AlbuTrol are assigned on factory calibrated HemoCue Albumin 201 systems." This implies internal expert consensus on how to perform and interpret these reference measurements, but specific numbers or qualifications are not detailed.
Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation) where human experts might disagree. For quantitative control materials, the ground truth is established by precise measurements on reference instruments, not by adjudicating expert opinions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a quality control material for in-vitro diagnostic systems, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC study comparing human performance with/without AI assistance is irrelevant to this product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a quality control material. It does not involve an algorithm, nor is it a standalone diagnostic tool in the typical sense. Its "performance" is its ability to have stable and accurate assigned values, and to behave like human urine when measured by the HemoCue systems.
The type of ground truth used:
- The ground truth for AlbuTrol is its assigned value, which is established via measurements on factory-calibrated reference instruments (HemoCue Albumin 201 systems) using validated methods. This is akin to a reference method or gold standard for control materials.
The sample size for the training set:
- Not applicable. This product is a quality control material, not a machine learning model. There is no "training set" in the context of developing this control material itself. The development involves formulation, stability testing, and value assignment, not algorithm training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this product. See point 7.

Summary

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K 060 2/5

510(k) Summarv

Submitter:	Eurotrol B.V.Keplerlaan 206716 BS Ede, The Netherlands
	+31 318 695777 (Telephone)+31 318 695770 (FAX)
Contact:	Allan White (Official Correspondent)HemoCue, Inc.40 Empire DriveLake 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 CFR862.1660, Product Code JJX)
Common Name:	AlbuTrol
Equivalent to:	MAS® UA Control, 510(k) document control number K023928

Description

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.

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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.

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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 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

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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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Regulation Number and Section

§ 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.