(88 days)
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No
The summary describes a transport medium for stool specimens and does not mention any computational analysis or AI/ML technologies.
No
The device is described as a transport and preservation system for stool specimens, not a device used to treat a disease or condition.
Yes
The device is used for the "examination of stool specimens for intestinal parasites," which is an act of diagnosing.
No
The device description clearly indicates a "single vial transport system," which is a physical container for stool specimens. This is a hardware component, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites." This involves testing a sample taken from the human body (stool) in vitro (outside the body) to provide information about a health condition (presence of intestinal parasites).
- Sample Type: It uses "stool specimens," which are biological samples taken from a patient.
- Procedures: It mentions procedures like "Concentration, permanent stained smear, and immunoassay procedures," all of which are common laboratory techniques used for in vitro diagnostic testing.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The REMEL Par-One™ fits this description.
N/A
Intended Use / Indications for Use
REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.
Product codes
LIO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 1998
Mary Ann Silvius Business Development Manager Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215-3594
Re: K981391 Trade Name: Par-One™ Regulatory Class: I Product Code: LIO Dated: April 15, 1998 Received: June 12, 1998
Dear Ms. Silvius:
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 Regulations, 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 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 regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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, "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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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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INDICATIONS FOR USE
| 510(k) Number (if known): | K981391 |
|---|---|
| --------------------------- | --------- |
Device Name: Par-One™
Indications For Use: REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.
(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 Laboratory Devices
| 510(k) Number | K981391 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |