(36 days)
Not Found
No
The device description and intended use focus solely on the physical components and mechanism of capillary blood collection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is indicated for collecting blood samples for diagnostic testing, not for treating any medical condition.
No
The device is a collection system for obtaining blood samples. It is indicated for the "purposes of obtaining a blood sample for diagnostic testing," meaning the blood collected by this device is then used for diagnostic testing, but the device itself does not perform the diagnosis.
No
The device description clearly states it is a "100 % plastic preassembled system made up of 4 components" which are physical hardware components used for blood collection. It does not describe any software functionality.
Based on the provided information, the SAFE-T-FILL® Capillary Blood Collection System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the collected blood sample is for the "purposes of obtaining a blood sample for diagnostic testing." This is a key characteristic of IVD devices, which are used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The device is designed to collect a biological specimen (blood) for subsequent processing and analysis.
- Predicate Devices: The listed predicate devices (StatSampler®, CapiJect® Capillary Blood Collection System, Microtainer® Tube with EDTA and Microgard™ Closure) are all known IVD devices used for blood collection for diagnostic testing.
While the device itself is a collection system and not the analytical instrument that performs the diagnostic test, it is an essential component in the IVD process by providing the sample required for the diagnostic test. Therefore, it falls under the scope of IVD devices.
N/A
Intended Use / Indications for Use
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic testing.
Product codes
JKA
Device Description
The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in different colors which identify the general type of additive or anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or heelstick
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
StatSampler® (K896206), CapiJect® Capillary Blood Collection System (K833475), Microtainer® Tube with EDTA and Microgard™ Closure (K931368)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 2 1998 O. Box 586, Needham, MA 02194 Phone: 800/535-6734 781/433-0766 Fax: 781/433-0767
510(k) SUMMARY
June 5, 1998
| Submitter: | RAM Scientific, Inc.
P.O. Box 586
Needham, Massachusetts 02194
Phone (781) 433-0766
Fax (781) 433-0767 |
| ------------ | -------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Monique Muri RAM Scientific, Inc. Phone (781) 433-0766 (781) 433-0767 Fax
Trade Name: SAFE-T-FILL® Capillary Blood Collection System
Common Name: Capillary blood collection system
Classification Name: Blood Specimen Collection Device
Predicate Device: StatSampler® (K896206); CapiJect® Capillary Blood Collection System (K833475); and Microtainer® Tube with EDTA and Microgard™ Closure (K931368).
The SAFE-T-FILL® Capillary Blood Collection System is a Description: collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in different colors which identify the general type of additive or anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.
The SAFE-T-FILL® Capillary Blood Collection System is Intended Use: indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for testing.
1
| Characteristic | SAFE-T-FILL® | StatSampler® | CapiJect® | Microtainer® |
|---|---|---|---|---|
| Combination capillary | ||||
| tube and microtube. | Yes | Yes | No | No |
| Available with different | ||||
| additives or | ||||
| anticoagulants | Yes | Yes | Yes | Yes |
| All Components Plastic | Yes | No | Yes | Yes |
| Used to collect, | ||||
| Anticoagulate and Store | ||||
| Skin Puncture Blood | ||||
| Specimens | Yes | Yes | Yes | Yes |
| Similar Hematological | ||||
| Determinations | Yes | Yes | Yes | Yes |
| Fill Lines | 125μl, 150 μl, & | |||
| 200 μl | 100μl & 200μl | 250μl, 500μl | ||
| & 625μl | 500 μl | |||
| Preassembled | Yes | No | Yes | Yes |
| Sterile | No | No | No | No |
Summary of Similarities and Differences of Predicate Devices
11 million
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 2 1998 Ram Scientific C/O Mr. Geoffrey M. Levitt Venable, Baetjer, Howard & Civiletti,LLP 1201 New York Avenue, N.W Suite 1000 Washington, DC 20005-3917
K983517 Re : SAFE-T-FILL® Capillary Blood Collection System Trade Name: Requlatory Class: II Product Code: JKA Dated: October 7, 1998 Received: October 7, 1998
Dear Mr. Levitt:
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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 leqally 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 diaqnostic 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 Toutman
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 /
| 510(k) Number (if known): | K983517 |
|---|---|
| --------------------------- | --------- |
Device Name:_
Indications For Use:
STATEMENT OF INDICATIONS FOR USAGE
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic testing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical La
510(k) Number. K98 3517
Prescription Use_ (Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
Over-The-Counter Use_