SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

K981973 · Ram Scientific · JKA · Sep 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981973
• Device Name: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
• Applicant: Ram Scientific
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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.

Device Story

SAFE-T-FILL® is a non-invasive, 100% plastic capillary blood collection system. Components include a capillary end-to-end tube, a colored sleeve, a microtube, and a cap. The microtube contains an anticoagulant. Operation involves collecting blood via capillary action from a finger or heelstick, transferring the blood into the microtube, capping, and mixing. The device is used in clinical settings by healthcare personnel to obtain blood samples for hematological testing. The system facilitates the collection, anticoagulation, and storage of skin puncture blood specimens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

100% plastic construction; preassembled system; capillary action collection; available with various anticoagulants; fill lines at 125μl, 150μl, and 200μl; non-sterile.

Indications for Use

Indicated for drawing capillary blood via finger or heelstick for diagnostic hematology testing in patients requiring blood specimen collection.

Regulatory Classification

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.

Predicate Devices

• StatSampler® (K896206)
• CapiJect® Capillary Blood Collection System (K833475)
• Microtainer® Tube with EDTA and Microgard™ Closure (K931368)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

3 1998 SEP

510(k) SUMMARY

June 5, 1998

| Submitter: | RAM Scientific, Inc.<br>P.O. Box 586<br>Needham, Massachusetts 02194<br>Phone [phone]<br>Fax [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Monique Muri<br>RAM Scientific, Inc.<br>Phone [phone]<br>Fax [phone] |
| 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<br>Collection System (K833475); and Microtainer® Tube with<br>EDTA and Microgard™ Closure (K931368). |
| Description: | The SAFE-T-FILL® Capillary Blood Collection System is a<br>collection device used to draw capillary blood from the finger<br>or heelstick. It is a non-invasive device. SAFE-T-FILL® is a<br>100 % plastic preassembled system made up of 4 components.<br>A capillary end-to-end tube, a colored sleeve which holds the<br>capillary, a microtube, and a cap. The sleeve and cap come inanticoagulant that is contained within the microtube. Blood is<br>collected into the capillary tube and allowed to flow into the<br>microtube. The tube is capped, mixed and then processed by<br>the user organization. |
| Intended Use: | The SAFE-T-FILL® Capillary Blood Collection System is<br>indicated for the drawing of blood via capillary action from a<br>finger or heelstick to be placed in a microtube for the purposes<br>of obtaining a blood sample for testing. |

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| Characteristic | SAFE-T-FILL® | StatSampler® | CapiJect® | Microtainer® |
|---------------------------------------------------------------------------------|----------------------------|---------------|-------------------------|--------------|
| Combination capillary<br>tube and microtube. | Yes | Yes | No | No |
| Available with different<br>additives or<br>anticoagulants | Yes | Yes | Yes | Yes |
| All Components Plastic | Yes | No | Yes | Yes |
| Used to collect,<br>Anticoagulate and Store<br>Skin Puncture Blood<br>Specimens | Yes | Yes | Yes | Yes |
| Similar Hematological<br>Determinations | Yes | Yes | Yes | Yes |
| Fill Lines | 125μl, 150 μl, &<br>200 μl | 100μl & 200μl | 250μl, 500μl<br>& 625μl | 500 μl |
| Preassembled | Yes | No | Yes | Yes |
| Sterile | No | No | No | No |

## Summary of Similarities and Differences of Predicate Devices

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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.

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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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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 -

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