(188 days)
Entero-Test®- (preamendments device), Entero-Test® Pediatric- (preamendments device)
Not Found
No
The device is a simple collection tool and the summary does not mention any AI/ML components or functions.
No.
The device is described as an "in-vitro diagnostic device" used for the "collection of fluid/mucous containing Helicobacter pylori," indicating its purpose is for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Entero-Test® HP is an in-vitro diagnostic device".
No
The device description clearly states it is a collection device consisting of a nylon thread and a gelatin capsule, which are physical components, not software.
Yes, the provided text explicitly states that the Entero-Test® HP is an in-vitro diagnostic device.
Here's why:
- Intended Use/Indications for Use: The very first sentence clearly states, "The Entero-Test® HP is an in-vitro diagnostic device..."
- Device Description: While describing the device, it reiterates that it is a "collection device encased in a gelatin capsule" used to collect fluids/mucous. The inclusion of a pH stick and color chart for identifying pH further supports its use in a diagnostic context.
- Summary of Performance Studies: This section discusses clinical tests and compares the device's performance to the "gold standard" of Biopsy for determining the presence of Helicobacter pylori in a sample specimen. This is a clear indication of its use in a diagnostic process.
Therefore, based on the provided information, the Entero-Test® HP is indeed an In Vitro Diagnostic (IVD) device.
N/A
Intended Use / Indications for Use
The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
The Entero-Test® HP is an in-vitro diagnostic device indicated for the collection of fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
Product codes (comma separated list FDA assigned to the subject device)
LIO
Device Description
The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper gastrointestinal tract of adults
Indicated Patient Age Range
Adults
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)
The clinical tests conducted for the Entero-Test® HP show that the In Vitro Diagnostic device is effective in collecting upper gastrointestinal tract fluid/mucous that contain Helicobacter pylori.
As Biopsy is considered the “gold standard” for determining the presence of Helicobacter pylori in a sample specimen, the performance of the Entero-Test® HP in successfully collecting fluids/mucous containing H. pylori was directly compared to the Biopsy results.
The comparative results of the studies in the U.S. and China do not show a significant difference (74% vs. 80% recovery). Both study sites indicate that the Entero-Test® HP is effective in collecting fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults in excess of seventy percent (70%) when compared to Biopsy test results.
In the studies described above, it was noted that the pH of retrieved stomach contents may affect specimen results, and is therefore so stated in the limitations under the Instructions for Use.
No adverse reactions or serious injuries were reported from both sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
74% vs. 80% recovery
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.
Entero-Test®- (preamendments device), Entero-Test® Pediatric- (preamendments device)
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.
Not Found
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.
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Image /page/0/Picture/3 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K983119'. The handwriting is somewhat stylized, with some characters connected and others distinct.
APPENDIX 4
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
The assigned 510(K) number is:________________________________________________________________________________________________________________________________________________
| Name of In-Vitro Diagnostic Device: | Entero-Test®IIP |
|---|---|
| Common Name: | Specimen Collection Device |
| Classification Name: | 83LIO |
| Predicate Devices: | Entero-Test®- (preamendments device) |
| Entero-Test® Pediatric- (preamendments device) | |
| Device Description: | The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous. |
| Intended Use: | The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule. |
| Device/Predicate Device Characteristics | The Entero-Test® HP retains the following characteristics of the predicate device: |
| Both devices are used for the collection of fluids/mucousBoth utilize the same operating principle |
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APPENDIX 4
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| Both incorporate the same device design Both have the same shelf life Both are packaged using same materials and process Both are sterilized utilizing the same validated method Both utilize exactly the same materials Both retain the same technological characteristics Both retain the same technological features Both devices have the same risk assessments | |
|---|---|
| Performance Data: | The clinical tests conducted for the Entero-Test® HP show that the In Vitro Diagnostic device is effective in collecting upper gastrointestinal tract fluid/mucous that contain Helicobacter pylori . |
| As Biopsy is considered the “gold standard” for determining the presence of Helicobacter pylori in a sample specimen, the performance of the Entero-Test® HP in successfully collecting fluids/mucous containing H. pylori was directly compared to the Biopsy results. | |
| The comparative results of the studies in the U.S. and China do not show a significant difference (74% vs. 80% recovery). Both study sites indicate that the Entero-Test® HP is effective in collecting fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults in excess of seventy percent (70%) when compared to Biopsy test results. | |
| In the studies described above, it was noted that the pH of retrieved stomach contents may affect specimen results, and is therefore so stated in the limitations under the Instructions for Use. | |
| No adverse reactions or serious injuries were reported from both sites. | |
| Conclusions: | Entero-Test® HP is a device that can be used to collect fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a sense of motion. The overall design is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 5 1999
Leonard O. Ross Vice President HDC Corporation 2109 O'Toole Avenue San Jose, CA 95131-1388
Re: K983119 Trade Name: Entero-Test® HP Regulatory Class: I Product Code: LIO Dated: December 29, 1998 Received: January 4, 1999
Dear Mr. Ross:
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 (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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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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APPENDIX 6
Indications for Use Statement
| 510(k) Number | K983119 |
|---|---|
| Device Name | Entero-Test @ HP |
| Indications for Use | The Entero-Test @ HP is an in-vitro diagnostic device indicated for the collection of fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-off)
Division of Cl Laboratory Devices 510(k) Number
Prescription Usc (Per 21 CFR 801.109) OR