The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

Device Description

The device is a kit containing the materials necessary to self-collect a capillary blood sample onto a filter paper card for transport to a certified clinical laboratory for lipid profile testing. The kit is comprised of a blood collection card packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, collection instructions, return prepaid envelope, and a patient test authorization form.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System." While it mentions performance studies and substantial equivalence, it does not explicitly state specific acceptance criteria or provide a detailed table comparing acceptance criteria with reported device performance.

However, I can infer some general performance aspects and describe the associated study based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not provided, this table will reflect the general performance claims and the comparison method.

Performance Metric	Acceptance Criteria (Inferred from "Substantially Equivalent")	Reported Device Performance (Summary)
Total Cholesterol	Results substantially equivalent to venous (serum) results	Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods.
HDL-Cholesterol	Results substantially equivalent to venous (serum) results	Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods.
Triglycerides	Results substantially equivalent to venous (serum) results	Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods.
LDL-Cholesterol (Calculated)	Results substantially equivalent to venous (serum) results (where triglycerides < 400 mg/dL)	Calculated from the above lipid profile; implied "substantially equivalent" if the direct measurements are. Not determinable if triglycerides > 400 mg/dL.
Precision	Not explicitly stated, but implied to be acceptable for clinical use.	Performance characteristics studied included precision.
Total Error	Not explicitly stated, but implied to be acceptable for clinical use.	Performance characteristics studied included total error.
Correlation	Not explicitly stated, but implied to be strong with venous samples.	Performance characteristics studied included correlation.
Sample Stability	Acceptable stability when exposed to abusive storage and transportation conditions.	Evaluated for sample stability when exposed to abusive storage and transportation conditions.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical trials" and "volunteer study subjects," but does not provide the number of subjects or samples.
Data Provenance:
- Country of Origin: Not explicitly stated, but likely the United States given the FDA submission and the company's address.
- Retrospective or Prospective: The study involved "volunteer study subjects" and the collection of "corresponding venous blood sample and a professionally collected capillary blood sample" alongside the self-collected samples, indicating a prospective study design.

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

This device is for in vitro diagnostic determination of lipid profiles, not interpretation by human experts. The ground truth would be established by laboratory analysis using predicate devices and validated methods, not expert consensus. Therefore, this section is not applicable in the traditional sense of human expert review.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for lipid levels is determined by established laboratory analytical methods, not by adjudication among human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic devices where human interpretation plays a significant role. For this in vitro diagnostic device, the comparison is between blood collection methods (self-collected capillary vs. venous/professionally collected capillary) and their analytical results.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable in the context of this device. The "device" is a blood collection and transport system. The analysis of the blood samples is performed by standard laboratory instruments and reagents (Synermed Cholesterol Reagent Kit, Sigma Diagnostics Infinity Triglyceride Reagents, Sigma Diagnostics EZ-HDL Cholesterol Reagents), which can be considered "standalone" in their analytical capacity once the sample is prepared. The study evaluates the sample quality and the method modifications used by BIOSAFE Laboratories to analyze these specific dried capillary blood spots.

7. The Type of Ground Truth Used

The ground truth used was comparative laboratory results from venous (serum) blood samples and professionally collected capillary blood samples, analyzed using predicate or established laboratory methods. This acts as the "gold standard" against which the self-collected capillary samples were compared.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device itself. The primary study described is a performance study comparing different sample types. If there was an internal development or optimization phase for their "modified analytical methods," the sample size used for that is not specified.

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

As no explicit training set for the device is mentioned, this is not applicable. The "ground truth" for the overall validation was established by standard laboratory analysis of venous and professionally collected capillary blood, as described in point 7.

Summary

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APR 0 3 2002

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1) Submitter's NameAddress, contact	BIOSAFE Laboratories, Inc.100 Field Drive, Suite 240Lake Forest, IL 60045Phone: (847) 234-8111FAX: (847) 234-8222
	Contact Person:	Jack A. Maggiore, PhDBIOSAFE Laboratories, Inc.(773) 693-0400, x253
	Date Prepared:	September 6, 2001
2) Device Name	Proprietary Name:	SAFE AT HOME CHOLESTEROL PROFILEBlood Collection and Transport System
	Common Name:	At-home capillary blood self-collection andtransportation system for Total Cholesterol,HDL-Cholesterol, Triglycerides and CalculatedLDL-Cholesterol
		Classification Names: Cholesterol (21 CFR 862.1175)HDL-Cholesterol (21 CFR 862.1475)Triglycerides (21 CFR 862.1705)LDL-Cholesterol (21 CFR 862.1475)
3) Predicate Devices	Total Cholesterol	Beckman Synchron Synchron CX SystemsCholesterol (CHOL) Reagent (K974046)
	HDL Cholesterol	Sigma EZ HDLTM Cholesterol Reagent(K972041)
	Triglycerides	Beckman Triglycerides Reagent Kit (K781939)
4) Device Description	The device is a kit containing the materials necessary to self-collect acapillary blood sample onto a filter paper card for transport to acertified clinical laboratory for lipid profile testing. The kit iscomprised of a blood collection card packaged in a foil pouch, alcoholprep pad, disposable lancets, gauze pad, bandage strip, collectioninstructions, return prepaid envelope, and a patient test authorizationform.
5) Intended Use	The SAFE AT HOME CHOLESTEROL PROFILE Blood Collectionand Transport System is intended for over-the-counter distribution,for the self-collection and transportation of dried capillary blood forin vitro diagnostic quantitative determination of Total Cholesterol,HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol indried blood spots. This kit is not intended for use on neonates. LDLcannot be determined where the triglyceride value is greater than 400mg/dL.Continued on next page

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510(k) Summary, continued

The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection 6) Comparison to and Transport System has technological characteristics that are predicate device substantially equivalent to that of the predicate devices listed above. The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System provides components that permit collection, storage, and transportation of a dried capillary blood sample to a certified clinical laboratory for analysis using FDA-Approved laboratory reagent and analysis systems. All predicate and current kits are intended for the in vitro diagnostic laboratory determination of lipid profile analytes. The laboratory analyses used in conjunction with (accessories of) the SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System, utilize the Synermed Cholesterol Reagent Kit (K903015), Sigma Diagnostics Infinity Triglyceride Reagents (K844032), and Sigma Diagnostics EZ-HDL Cholesterol Reagents (K972041). Results of clinical trials show that self-collected capillary samples onto the BIOSAFE Blood Collection Card provide results that are substantially equivalent to venous (serum) results for Total Cholesterol, HDL-Cholesterol and Triglycerides when analyzed using BIOSAFE Laboratories modified analytical methods.
Determination of self-collected capillary blood Total Cholesterol, 7) Performance Studies HDL Cholesterol and Triglycerides using the SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile testing BIOSAFE Laboratories modified analytical methods. Performance studies were conducted on self-collected capillary blood samples from volunteer study subjects at three different geographical sites. A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare serum lipid results to those obtained from both capillary blood samples collected onto the BIOSAFE Blood Collection Card. Venous samples were express shipped, and dried capillary samples were mailed directly to BIOSAFE Laboratories for lipid profile analysis by their respective methods.

Test Summary

Performance characteristics studied included precision, total error and In addition, the SAFE AT HOME CHOLESTEROL correlation. PROFILE Blood Collection and Transport System was evaluated for sample stability when exposed to abusive storage and transportation conditions.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jack Maggiore, Ph.D. Director, Clinical Trials BIOSAFE Laboratories, Inc. 100 Field Drive - Suite 240 Lake Forest, IL 60045

APR 0 3 2002

K012221 Re:

Trade/Device Name: Safe At Home Cholesterol Profile Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: March 6, 2002 Received: March 7, 2002

Dear Dr. Maggiore:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nourication. The 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 1 11 you active open 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, ( Jor Jos at the Office of Compliance at (301) 594-4639. 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 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/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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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C. Indications for Use Statement

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(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_L_O 12 ここ

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Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.