SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

K983517 · Ram Scientific · JKA · Nov 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983517
• Device Name: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
• Applicant: Ram Scientific
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 12, 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 diagnostic testing.

Device Story

SAFE-T-FILL® is a non-invasive, preassembled capillary blood collection system. Components include a capillary end-to-end tube, colored sleeve, microtube, and cap. The system uses capillary action to draw blood from a finger or heelstick; blood flows into the microtube. Sleeves and caps are color-coded to identify additives or anticoagulants within the microtube. The device is used by healthcare personnel to collect, anticoagulate, and store skin puncture blood specimens for hematological determinations. The system is entirely plastic. After collection, the tube is capped, mixed, and processed by the user organization.

Clinical Evidence

Bench testing only.

Technological Characteristics

100% plastic construction; preassembled system consisting of capillary tube, colored sleeve, microtube, and cap. Capillary action collection principle. Available with various additives/anticoagulants. Fill lines at 125μl, 150μl, and 200μl. Non-sterile.

Indications for Use

Indicated for drawing capillary blood from finger or heelstick for diagnostic testing.

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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K983517

NOV 1 2 1998 O. Box 586, Needham, MA 02194 Phone: [phone] Fax: [phone]

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] |
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|------------|--------------------------------------------------------------------------------------------------------------------|

Contact Person: Monique Muri RAM Scientific, Inc. Phone [phone] [phone] 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.

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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

11 million

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## 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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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 [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, "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 [phone] or [phone], 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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| 510(k) Number (if known): | K983517 |
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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_