APPRAISE-CARDIO SAMPLE COLLECTION KIT

K993787 · Osborn Group, Inc. · JKA · Apr 14, 2000 · Clinical Chemistry

Device Facts

• Record ID: K993787
• Device Name: APPRAISE-CARDIO SAMPLE COLLECTION KIT
• Applicant: Osborn Group, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Apr 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Appraise-Cardio Sample Collection Kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

Device Story

Kit facilitates remote blood sample collection for lipid panel testing. Components include collection tube, capillary tube, lancet, alcohol swab, gauze, bandage, and mailing materials. Patient performs finger-stick at home or office; blood transferred to collection tube; tube labeled with barcoded patient ID; specimen mailed to laboratory. Laboratory processes sample using existing reagent kits to measure total cholesterol, triglycerides, HDL, and LDL. Results mailed to ordering physician for clinical evaluation. Enables convenient patient monitoring of lipid levels without immediate clinic visit.

Clinical Evidence

Bench testing only. Environmental testing performed to ensure whole blood samples maintain integrity for lipid analysis (total cholesterol, triglycerides, HDL, LDL) under extreme temperature and humidity conditions simulating U.S. Mail transit. Results were within acceptable limits.

Technological Characteristics

Kit includes collection tube, capillary tube, lancet, alcohol swab, gauze, and adhesive bandage. Components are legally marketed, commercially available items. No electronic or software components. Environmental stability maintained via packaging design.

Indications for Use

Indicated for patients requiring blood specimen collection for lipid panel analysis (total cholesterol, triglycerides, HDL, LDL). Prescription use only; suitable for home or physician office collection.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Diabetes Technologies, Inc. Accu-Base Hemoglobin Arc Sample Collection Kit (K983172)

Submission Summary (Full Text)

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Image /page/0/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, it says "A ChoicePoint Company" in a smaller font.

#### 510(k) SUMMARY

#### Osborn Group, Inc.

## Appraise-Cardio Sample Collection Kit

November 8, 1998

#### Submitter Information:

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

Submitter's Name: Phone:

Gilbert P. Bourk III [phone]

## Device Name:

Proprietary Name:

Common Name:

Classification Name:

Cholesterol (total) test system Triglyceride test system Lipoprotein test system

Blood Sample Collection Kit

Osborn Group Appraise-Cardio Sample Collection Kit

## Predicate Device Equivalence:

Substantial equivalence is claimed to the Diabetes Technologies, Inc. Accu-Base Hemoglobin Arc Sample Collection Kit, cleared for commercial distribution per K983172.

## Device Description:

The Appraise-Cardio Sample Collection Kit is a Sample Collection Kit which is sent to the patient's home after the kit has been ordered by the patient's physician. The kit consists of the following:

- A Sample Collection Tube. -
- A Sample Collection Capillary Tube. -
- -A Sample Tube Holder Box.
- A Patient Identification Card which contains the patient's name, address, Social Security Number, t information, the physician's name and phone number and a bar code number that is peeled off and affixed to the Sample Collection Tube after the sample has been taken.
- A pamphlet containing detailed information about the lipid program and instructions on how to obtain a blood sample and mail it to a laboratory.

Image /page/0/Picture/25 description: The image shows the logo for Osborn Laboratories. The logo consists of a circular design made up of small squares, with the letters "OSBORN LABORATORIES" printed below it. Underneath the company name, it says "A ChemPoint Company" in a smaller font.

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- A plastic zip lock bag marked "Specimen Collection Envelope" into which the Sample Collection Tube is placed.
- An absorbent pad that is contained in the Specimen Collection Envelope. -
- A plastic zip lock bag marked "Waste". -
- A self-adhesive envelope in which the specimen envelope is inserted and then mailed to the preprinted address on the envelope.
- -A sterile lancet
- -An alcohol swab
- A sterile gauze pad -
- -A sterile adhesive bandage
- The mailing envelope which is used to mail the above items to the patient. .

The Sample Collection Tube, Sample Collection Capillary Tube, lancet, alcohol swab, gauze pad and adhesive bandage are all legally marketed, commercially available items.

After receiving the Appraise-Cardio Sample Collection Kit in the mail, the patient then collects a blood sample, using a lancet supplied in the kit or purchased separately by the patient. The blood sample is placed in the Sample Collection Tube as described in the instructions. The bar code sticker from the Patient Identification Card is then affixed to the Sample Collection Tube which is then placed in the Specimen Collection Envelope. The Patient Information Card and Specimen Collection Envelope are then placed in the mailing envelope. The mailing envelope is then sealed and sent to a laboratory for processing. When the blood sample is received by the laboratory the patient's total cholesterol, triglycerides and HDL values are measured using existing reagent kits.

## Intended Use:

The Appraise-Cardio Sample Collection Kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

## Comparison of Technological Characteristics:

Essentially, the two devices use the same basic technology, i.e., collecting a whole blood sample and analyzing it using an existing assay methodology. However, the blood parameters being measured are different for the two devices and thus the assay methodologies are different.

## Summary of Device Testing:

To obtain assurance that the whole blood samples would still provide an accurate assessment of the patients' total cholesterol, triglycerides. HDL and LDL even after undergoing the extreme temperatures and humidity conditions that can be experienced by any object sent by U.S. Mail, the Appraise-Cardio Sample Collection Kit was subjected to environmental testing. The results were within acceptable limits.

#### Conclusions:

Based on the above, we concluded that the Appraise-Cardio Sample Collection Kit is substantially equivalent to a legally marketed predicate device and is safe 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 4 2000

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

Re: K993787

> Trade Name: Appraise-Cardio Sample Collection Kit Regulatory Class: II Product Code: JKA Dated: March 10, 2000 Received: March 13, 2000

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 (OS) 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Steven Sutman

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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Page of of

510(k) Number (if known): K993787

Device Name:

Appraise-Cardio Sample Collection Kit

# Indications for Use:

The Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

Cooper
il an
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number 1x993787

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)