(84 days)
Not Found
Para-Pak CON-Trate
No
The device description details a mechanical process of filtration and centrifugation, with no mention of software, algorithms, or any form of computational analysis that would suggest AI/ML.
No
This device is for the concentration of biological elements from fecal specimens for diagnostic examination, not for treating a disease or condition.
Yes
Explanation: The device is used to concentrate and prepare fecal specimens for the detection of parasites, which is a step in diagnosing parasitic infections.
No
The device description clearly outlines physical components like "SPINCON Caps," "SPINCON Preliminary Funnel Screens," and "Para-Pak Surfactant," indicating it is a hardware-based system for specimen processing.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "for the concentration of eggs, larvae, and protozoa from preserved fecal specimens." This process is performed in vitro (outside the living body) on a biological specimen (fecal matter) to aid in the diagnosis of parasitic infections.
- Device Description: The description details a process of preparing a biological specimen for microscopic examination to identify specific biological entities (parasites). This is a core function of many IVD devices used in clinical laboratories.
- Specimen Type: The device is designed to work with "preserved fecal specimens," which are biological samples collected from a patient.
- Purpose: The ultimate goal of using this device is to facilitate the identification of parasites, which is a diagnostic step in determining the cause of a patient's symptoms.
The fact that it doesn't involve image processing, AI, or specific performance metrics like sensitivity and specificity doesn't preclude it from being an IVD. Many IVDs are sample preparation devices that are crucial steps in a diagnostic workflow, even if they don't directly perform the final analysis or interpretation.
N/A
Intended Use / Indications for Use
Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
Product codes (comma separated list FDA assigned to the subject device)
LKS
Device Description
Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.
SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies demonstrate equivalent performance and recovery
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Para-Pak CON-Trate
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KA80077
APR - 2 1998
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Para-Pak SPINCON
APPENDIX A - 510(k) Summary
A. Identification Information
- Submitter's Information: 1)
- a) Submitter's Name and Address:
Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244
- b) Phone Number: 1-800-543-1980
- c) Contact Person: Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs
- d) Date Summary Prepared: December 24, 1997
- Name of Device: Para-Pak SPINCON. 2)
Classification Name: Device, Parasite Concentration 83LKS
- Predicate Equivalent Device: Para-Pak CON-Trate 3)
- Description of Device: Para-Pak SPINCON involves passing a surfactant treated, 4) preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.
SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
1
Meridian Diagnostics, Inc. Cincinnati, OH 45244
ﻟ
- Intended Use: Para-Pak SPINCON is a unique, patent pending system for the ર) concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
- Comparison with Predicate Device: The following comparison of the use, 6) technology, function and performance supports the Statement of Equivalence with the predicate device.
| Method | Para-Pak®
SPINCON | Para-Pak®
CON-Trate |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | System for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces | |
| Results | Final pellet consists of concentrated parasites | |
| Technology | Utilizes filtration and centrifugation | |
| Function | Treat stool with surfactant.
Filter through primary funnel with mesh screen.
Add saline.
Centrifuge through series of smaller mesh
screens.
Remove supernatant.
Resuspend in fixative.
Prepare wet mount. | Treat stool with surfactant.
Filter through primary Funnel with mesh screen.
Add saline.
Centrifuge.
Remove supernatant.
Resuspend in buffered formalin and ethyl
acetate.
Centrifuge.
Remove supernatant.
Prepare wet mount. |
| Final Pellet | Useable for saline or iodine wet mount microscopic evaluation | |
| Performance | Clinical studies demonstrate equivalent performance and recovery | |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
APR - 2 1998
Re: K980077 Trade Name: Para-Pak® SPINCON Regulatory Class: I Product Code: LKS Dated: June 30, 1997 Received: March 25, 1998
Dear Dr. Nickol:
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 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 (OS) 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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Page 2
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 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
4
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Para-Pak SPINCON
Indications for Use Statement: C.
510(k) Number (if known): __ NA K980077
Device Name: Para-Pak® SPINCON
Indications For Use: Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bla
(Division Sign-Off)
Division of Clinical Laboratory Devices K980077 510(k) Number_
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
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