(93 days)
The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for 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.
The device is a kit containing the materials necessary to 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.
Here's an analysis of the provided text to extract the acceptance criteria and details about the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K011970) is a 510(k) summary for a blood collection and transport system, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing specific performance acceptance criteria with numerical targets.
The document states: "Results of clinical trials show that professionally 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."
It further states: "Determination of professionally collected capillary blood Total 7) Performance Studies Cholesterol, HDL Cholesterol and Triglycerides using the BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile BIOSAFE Laboratories modified analytical methods testing."
Given this, the acceptance criteria are qualitative, centered around robust statistical equivalence to established venous blood testing methods, rather than specific numerical thresholds for accuracy, sensitivity, or specificity. The device performance is reported as meeting this "substantial equivalence."
| Acceptance Criteria (Stated Qualitatively) | Reported Device Performance |
|---|---|
| Substantial equivalence to venous (serum) results for total cholesterol | Provided results substantially equivalent to venous (serum) results for Total Cholesterol |
| Substantial equivalence to venous (serum) results for HDL cholesterol | Provided results substantially equivalent to venous (serum) results for HDL Cholesterol |
| Substantial equivalence to venous (serum) results for triglycerides | Provided results substantially equivalent to venous (serum) results for Triglycerides |
| Capable of determining Calculated LDL-Cholesterol | Yes, when triglyceride values are not greater than 400 mg/dL |
| Stability of samples under abusive storage/transportation conditions | Evaluated; performance characteristics studied included precision, linearity and correlation, and sample stability |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a specific number for the sample size. It mentions "volunteer study subjects" and "professionally collected blood samples from volunteer study subjects at three different geographical sites."
- Data Provenance: The study was conducted using prospective data collection. The subjects were volunteers, and samples were collected specifically for this study. The data was collected from "three different geographical sites." The country of origin is not explicitly stated, but given the FDA 510(k) submission, it's highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of "experts" to establish ground truth in the traditional sense of image or clinical interpretation.
- The ground truth for the study was established by laboratory analysis of venous blood samples using FDA-Cleared laboratory reagent and analysis systems. The "experts" in this context would be the certified clinical laboratory professionals performing the analyses and the established analytical methods themselves. The document states: "A corresponding venous blood sample was collected by the health care professional in order to compare serum lipid results to those obtained from capillary blood samples collected onto the BIOSAFE Blood Collection Card."
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation where an adjudication method like 2+1 or 3+1 would be relevant. The ground truth was based on laboratory analysis, which inherently includes internal quality controls and standardized procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on the analytical performance of the collection and transport system against standard laboratory methods, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "device" in question is a blood collection and transport system. The performance study evaluates the standalone analytical performance of the collected capillary blood samples (after transport and preparation) when run on standard laboratory analytical systems (Synermed Cholesterol Reagent Kit, Sigma Diagnostics Infinity Triglyceride Reagents, Sigma Diagnostics EZ-HDL Cholesterol Reagents). The "algorithm" here is the combined process of collection, transport, and subsequent laboratory analysis, without direct human intervention in the final analytical measurement itself. The comparison is between the results from the dried capillary blood spots via this process and the results from standard venous serum samples.
7. The Type of Ground Truth Used
The type of ground truth used was laboratory analysis results from venous (serum) blood samples. These are considered the gold standard for lipid profile determination.
8. The Sample Size for the Training Set
Not applicable. This type of device and study does not involve a "training set" in the context of machine learning or AI development. The device's performance is based on its physical/chemical properties and the established analytical methods, not on a learned model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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| 510(k) Summary | K011970 | ||
|---|---|---|---|
| 1) | Submitter's NameAddress, contact | BIOSAFE Laboratories, Inc.100 Field Drive, Suite 240Lake Forest, IL 60045 | |
| Phone: (847) 234-8111FAX: (847) 234-8222 | |||
| Contact Person: | Jack A. Maggiore, PhDBIOSAFE Laboratories, Inc.(773) 693-0400, x253 | ||
| Date Prepared: | August 22, 2001 | ||
| 2) Device Name | Proprietary Name: | BIOSAFE CHOLESTEROL PROFILEBlood Collection and Transport System | |
| Common Name: | 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 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 BIOSAFE CHOLESTEROL PROFILE Blood Collection andTransport System is intended for prescription distribution, and is aclinic-use device for collection and transportation of dried capillaryblood for in vitro diagnostic quantitative determination of TotalCholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on | ||
| Continued on next page | neonates. LDL cannot be determined where the triglyceride value isgreater than 400 mg/dL |
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- The BIOSAFE CHOLESTEROL PROFILE Blood Collection and 6) Comparison to Transport System has technological characteristics and an intended predicate device use that are substantially equivalent to that of the predicate devices listed above. The BIOSAFE 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-Cleared 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 the BIOSAFE 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 Results of clinical trials show that Reagents (K972041). professionally 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 professionally collected capillary blood Total 7) Performance Studies Cholesterol, HDL Cholesterol and Triglycerides using the BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile BIOSAFE Laboratories modified analytical methods. testing Performance studies were conducted on professionally collected blood samples from volunteer study subjects at three different geographical sites. A corresponding venous blood sample was collected by the health care professional in order to compare serum lipid results to those obtained from 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.
Performance characteristics studied included precision, linearity and correlation. In addition, the BIOSAFE CHOLESTEROL PROFILE 8) Test Summary 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jack A. Maggiore, Ph.D. Director, Clinical Trials BIOSAFE Laboratories, Inc. 100 Field Drive - Suite 240 Lake Forest, IL 60045
SEP 2 6 2001
K011970 Re:
Trade/Device Name: BIOSAFE Cholesterol Profile Blood Collectionand Transport System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Regulatory Class: Class I, reserved Product Code: CHH, LBS, CDT Dated: August 23, 2001 Received: September 4, 2001
Dear Dr. Maggiore:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the encreations of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, atere, mains of the Act include requirements for annual registration, listing of general voltared pro resuring 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 If your device is classified (600 wor ols. Existing major regulations affecting your device can may be subject to back as a saccrations, 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 i loast be advisou that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must or uny I cacal batales and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607); adoning (21 CFR Part 820); and if applicable, the electronic forul in the quality by seaths (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 I Dri Imaling of succion 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 CFF Part 801 and 1 IT you desire specific daily of the diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in The clagitestions on the promotion and advertising of your device, (301) 594-4566. Runnenally, spiliance 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 Information on your responsibilities and er Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
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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C. Indications for Use Statement
The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for Dystem is mended for pion of dried capillary blood for in vitro diagnostic concetion and "thisportation" of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on Caromates. LDL Cholosteror in aired where the triglyceride value is greater than 400 mg/dL.
\checkmark prescription use
Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.