(261 days)
No
The device description and performance studies focus on the collection and transport of blood samples for standard laboratory analysis, with no mention of AI/ML in the process or analysis.
No
The device is described as a "Blood Collection and Transport System" intended for "in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots." Its purpose is to collect and transport samples for diagnostic testing, not to treat or prevent a disease.
Yes
The device is intended for the self-collection and transportation of dried capillary blood for the in vitro diagnostic quantitative determination of various cholesterol levels. The results are obtained through analysis in a certified clinical laboratory, indicating its role in diagnosis.
No
The device description clearly outlines a physical kit containing various hardware components for blood collection and transport, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is for the "in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots." The term "in vitro diagnostic" is a direct indicator.
- Purpose: The device is designed to collect a biological sample (blood) for analysis outside of the body (in vitro) to provide information about a person's health status (cholesterol profile). This is the core function of an IVD.
- Analysis in a Laboratory: The collected sample is transported to a "certified clinical laboratory for lipid profile testing," which is where the diagnostic analysis takes place.
The device itself is a collection and transport system, but its intended purpose is to facilitate an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Capillary blood
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Self-collection, over-the-counter distribution. Samples transported to a certified clinical laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, 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 characteristics studied included precision, total error and correlation. In addition, the SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System was evaluated for sample stability when exposed to abusive storage and transportation conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
APR 0 3 2002
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
:
: :
:
:
:
G-1
| 1) Submitter's Name
Address, contact | BIOSAFE Laboratories, Inc.
100 Field Drive, Suite 240
Lake Forest, IL 60045
Phone: (847) 234-8111
FAX: (847) 234-8222 | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jack A. Maggiore, PhD
BIOSAFE Laboratories, Inc.
(773) 693-0400, x253 |
| | Date Prepared: | September 6, 2001 |
| 2) Device Name | Proprietary Name: | SAFE AT HOME CHOLESTEROL PROFILE
Blood Collection and Transport System |
| | Common Name: | At-home capillary blood self-collection and
transportation system for Total Cholesterol,
HDL-Cholesterol, Triglycerides and Calculated
LDL-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 Systems
Cholesterol (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 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. | |
| 5) Intended Use | 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.
Continued on next page | |
1
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.
2
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.
3
Page 2 -
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
4
C. Indications for Use Statement
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.
Alberto Sinti for kaiser Azi.
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_L_O 12 ここ
✓