PARA-PRO FC50

K053257 · Alpha-Tec Systems, Inc. · LKS · May 12, 2006 · Microbiology

Device Facts

• Record ID: K053257
• Device Name: PARA-PRO FC50
• Applicant: Alpha-Tec Systems, Inc.
• Product Code: LKS · Microbiology
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

Device Story

Para-Pro™ fc50 is a filtration device for processing human fecal specimens. It consists of a cone-shaped filter with 1.6 mm² openings designed to attach to a 30ml specimen vial and a 50ml centrifuge collection tube. The device creates a closed system; gravity filtration separates large fecal debris from the preserved specimen, allowing parasitic forms to pass into the collection tube. The resulting sediment is then processed via standard formalin-ethyl acetate or CONSED methods and examined microscopically by laboratory personnel. The device improves recovery of parasitic stages compared to traditional methods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Specimen collection and transport device for fecal matter. Designed for use with chemical preservatives including 10% buffered formalin, SAF, and Proto-fix™ CLR. Mechanical separation principle for debris removal and parasite concentration. Non-electronic, manual operation.

Indications for Use

Indicated for the concentration of eggs, larvae, protozoa, and juvenile nematodes from fecal specimens in patients suspected of having intestinal infections.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAY 12 2006

Mr. Richard Williams President/CEO Alpha-Tec Systems, Inc. 12019 NE 99th Street Building 17, Mail Stop 1780 Vancouver, WA 98682

Re: k053257

> Trade/Device Name: Para-Pro™ fc 50 Regulation Number: 21 CFR 866.2990 Regulation Name: Microbiology Specimen Collection and Transport Device Regulatory Class: Class I Product Code: LKS Dated: April 11, 2006 Received: April 13, 2006

Dear Mr. Williams:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally, a Toy

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):____ k053257

Device Name:__________________________________________________________________________________________________________________________________________________________________ Para-Pro™ fc50

Indications For Use:

Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddutu Poole
Division Sign-Off

vision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053257