(90 days)
Not Found
No
The device description and intended use clearly describe a manual capillary blood collection system with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device's stated purpose is for collecting blood samples for diagnostic testing, not for treating or preventing a disease or condition.
No
Explanation: The device is described as a "Capillary Blood Collection System" used for "drawing of blood" and placing it into a microtube for testing. It is a "collection device," not a device that performs diagnostic analysis itself. While the collected blood sample may be used for diagnostic testing ("diagnostic hematology testing"), the device itself is for collection, not diagnosis.
No
The device description clearly outlines physical components (capillary tube, sleeve, microtube, cap) made of plastic, indicating it is a hardware device for blood collection, not software.
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 device is for "obtaining a blood sample for testing" and specifically "for the purposes of obtaining a blood sample for diagnostic hematology testing." This clearly indicates that the collected sample is intended for in vitro diagnostic procedures.
- Device Description: The description details a system for collecting blood and preparing it for processing by a "user organization," which aligns with the workflow of diagnostic testing.
- Predicate Devices: The listed predicate devices (StatSampler®, CapiJect®, Microtainer® Tube) are all well-known capillary blood collection systems used in clinical laboratories for diagnostic testing. This further supports the classification of the SAFE-T-FILL® as an IVD.
While the device itself is a collection system and not the diagnostic test itself, it is a crucial component used in vitro (outside the body) to prepare a sample for in vitro diagnostic testing. 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 testing.
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 hematology testing.
Product codes (comma separated list FDA assigned to the subject device)
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 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): 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.
Not Found
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
KG81973
Image /page/0/Picture/1 description: The image shows the logo for RAM Scientific, Inc. The logo features a stylized ram's head inside a letter "R" on the left. To the right of the ram's head is the text "RAM SCIENTIFIC, INC." Below the company name is the address "P.O. Box 586, Needham, MA 02194".
P.O. Box 586, Needham, MA 02194 Phone: 800/535-67 14 781/433-0766 Fax: 781/433-0767
3 1998 SEP
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
Fax (781) 433-0767 |
| 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). |
| 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 inanticoagulant 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. |
| Intended 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 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
)
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
SEP 3 1698
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ram Scientific C/O Mr. Geoffrey M. Levitt Venable, Baetjer, Howard & Ceviletti, LLP 1201 New York Avenue, N.W., Suite 1000 Washington, D.C. 20005-3917
Re: K981973/S1
Trade Name: SAFE-T-FILL® Capillary Blood Collection System Regulatory Class: II Product Code: JKA Dated: July 31, 1998 Received: July 31, 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulatory 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.
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 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 (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, "Misbrandinq 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
INDICATIONS FOR USE
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of The SATE-T-THEE® Capillary 21000 On heelstick to be placed in a microtube for the olood via capinary asaon not sample for diagnostic hematology testing.
Peter E. Maples
(Division Sign-Off) (Elicion of Clinical Laboratory Devices
510(k) Number 510(k) Number -
Rv i