(32 days)
ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens.
Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen.
The filtered specimen may then be concentrated by centrifugation, and observed microscopically.
ParaCon II / Fecal Concentrator II is a filtration device.
The provided text is a 510(k) premarket notification letter from the FDA to Para Scientific, Inc. regarding their ParaCon II / Fecal Concentrator II device. This document is a regulatory approval letter and does not contain the acceptance criteria, study details, or performance data typically found in a scientific study or a detailed technical submission for a medical device.
Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed based on its stated indications for use. It doesn't include the specific study details that would demonstrate how acceptance criteria were met.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 0 4 2002
Mr. Eric Carlson Vice President Para Scientific, Inc. 17170 Wall Street Lake Oswego, OR 97034
Re: K021420
Trade/Device Name: ParaCon II / Fecal Concentrator II Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological Specimen Collection and Transport Device Regulatory Class: Class I Product Code: LKS Dated: April 30, 2002 Received: May 3, 2002
Dear Mr. Carlson:
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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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 1 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. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/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 Radiological Health
Enclosure
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510(k) Number (if known):__K021420
Device Name: ParaCon II / Fecal Concentrator II
Indications For Use:
ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens.
Fecal specimens thatthave been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen.
The filtered specimen may then be concentrated by centrifugation, and observed microscopically.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED)
Msion Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number_koal 1430 Prescription Use V Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801-109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
§ 866.2900 Microbiological specimen collection and transport device.
(a)
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.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.