The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.

Device Description

The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following:

A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
A Specimen Tube with a screw-on lid, containing preservative fluid.
A clear plastic sealed envelope that contains both of the above items.
A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
A set of instructions.
A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
A mailer into which the zip lock bag is placed.
A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.

AI/ML Overview

The provided text describes a 510(k) summary for the HemoChek Urine Collection Kit, a device intended for collecting and preserving urine specimens for laboratory testing of creatinine and microalbumin concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed table of exact performance metrics. Instead, the "Summary of Device Testing" section provides a qualitative statement about the device's performance relative to preserved urine.

Acceptance Criterion (Inferred)	Reported Device Performance
Equivalence of collected specimen to preserved urine	"The test results demonstrated that the samples collected with the HemoChek device produce substantially the same results as specimens of preserved and unpreserved urine" when tested for creatinine and microalbumin concentrations. This implies that the device's collection and preservation method maintains the integrity of these analytes comparable to established methods.
Suitability for intended use (collection and preservation)	The study's conclusion, "HemoChek Urine Collection Kit is substantially equivalent to legally marketed predicate devices and effective for its intended use," suggests that the device successfully performs its core functions of collection and preservation without negatively impacting the analytical results.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size ("number of urine pools" or "number of specimens") used for the testing. It vaguely states: "several tests were conducted from the same urine pool".
Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the involvement of experts to establish a "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" in this study refers to the chemical concentrations of creatinine and microalbumin in urine specimens. This "ground truth" would be established by laboratory analysis using validated assays on both HemoChek collected samples and comparator (preserved and unpreserved) urine samples. It is implied that standard laboratory practices and accredited testing methods were used to determine these concentrations, but details about the specific laboratory or personnel qualifications are not provided.

4. Adjudication Method for the Test Set

Not applicable. This study focuses on the analytical performance of the collection and preservation method for specific biochemical markers, not on the interpretation of medical images or diagnostic decisions that would typically require an adjudication method among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically used to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. This document describes the evaluation of a physical urine collection and preservation device, not an AI algorithm, and therefore an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical urine collection kit, not an algorithm. The "standalone performance" in this context refers to the device's ability to collect and preserve urine specimens such that the analytes within remain stable for subsequent laboratory testing, which is implicitly what the "Summary of Device Testing" addresses.

7. Type of Ground Truth Used

The ground truth used was laboratory analytical results for creatinine and microalbumin concentrations. The comparison was made between:

Specimens collected with the HemoChek device
Preserved urine specimens (presumably collected using a standard, established preservation method)
Unpreserved urine specimens (presumably tested immediately or under controlled conditions)

The "ground truth" for the HemoChek device's performance was its ability to yield "substantially the same results" as these comparator samples.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device (urine collection kit), not a machine learning model or algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Osborn Group, Inc., along with the text "A ChoicePoint Company". Above the logo, the date "SEP 2 4 1999" is printed. The logo is in black and white and features a stylized design.

510(k) SUMMARY

Osborn Group, Inc HemoChek Urine Collection Kit

May 25, 1999

Submitter Information:

Osborn Group, Inc. 19401 West 117th Street Olathe, Kansas 66062

Submitter's Name: Gilbert P. Bourk III (913) 390-7146 Phone:

Device Name:

Osborn Group, Inc. HemoChek Urine Collection Kit

Common Name: Urine collection kit

Classification Name: Specimen container

Predicate Device Equivalence:

Substantial equivalence is claimed to the Osborn Group, Inc. Oral-Eze™ Oral Fluid Collection System (primary predicate device) and the Sage Products Inc. Midstream Collection Kit , cleared for commercial distribution per K984361and K800947, respectively.

Device Description:

A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
.. A Specimen Tube with a screw-on lid, containing preservative fluid.
-A clear plastic sealed envelope that contains both of the above items.

Image /page/0/Picture/19 description: The image shows the logo for Osborn Laboratories. The logo consists of a stylized letter "L" that is filled with a grid pattern. To the right of the "L" are the words "OSBORN LABORATORIES" in a sans-serif font. Below the words "OSBORN LABORATORIES" are the words "A ChoicePoint Company" in a smaller font.

Image /page/0/Picture/20 description: The image shows the logo for Intellisys, which is an Osborn company. The logo is in black and white, with the word "INTELLISYS" in large, bold letters. Below the word "INTELLISYS" is the phrase "AN OSBORN COMPANY" in smaller letters. There is a curved line above the right side of the word "INTELLISYS".

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. A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
-A set of instructions.
-A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
-A mailer into which the zip lock bag is placed.
A polvethylene mailing envelope which contains all of the above items and is used to mail the -HemoChek Urine Collection Kit to the patient.

Intended Use:

The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream, or by dipping the absorbent pad in a cup contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testina of creatinine and microalbumin concentrations.

Comparison of Technological Characteristics:

The HemoChek Urine Collection Kit is physically identical to the primary predicate device, the Oral-Eze Oral Fluid Collection Device. The method used to collect a midstream urine specimen is identical to that used by the secondary predicate device, the Sage Products Inc. Midstream Collection Kit.

Summary of Device Testing:

To assess the capability of the HemoChek Urine Collection Kit to obtain a urine specimen that is equivalent to preserved urine, several tests were conducted from the same urine pool, with specimens collected using the HemoChek device and preserved urine. The test results demonstrated that the samples collected with the HemoChek device produce substantially the same results as specimens of preserved and unpreserved urine.

Conclusions:

Based on the above, we have concluded that the HemoChek Urine Collection Kit is substantially equivalent to legally marketed predicate devices and effective for its intended use.

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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 three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 1999

Mr. Gilbert P. Bourk III Vice President and General Counsel Osborn Group, Inc. 14901 West 117th Street Olathe, Kansas 66062

K991800 Re:

Trade Name: HemoChek Urine Collection Kit Regulatory Class: I Product Code: JIQ, CGX, FMH Dated: July 20, 1999 Received: July 21, 1999

Dear Mr. Bourk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Osborn Group, Inc. The logo features the company name in a bold, sans-serif font, with a curved line above the "O" in Osborn. Below the company name is the text "A ChoicePoint Company" in a smaller font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other communications.

Device Name:

K991800

HemoChek Urine Collection Kit

Indications for Use:

510(k) reventer

ún
Jean Coogh
(Division Sign-Off)
Divisie of Clinical Laboratory Devices

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Image /page/4/Picture/8 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

Image /page/4/Picture/9 description: The image shows the word "INTELLISYS" in all caps. The word is underlined, and there is a curved line above the word. There is a period after the word.

Regulation Number and Section

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
Identification. 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.(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.