(92 days)
Not Found
No
The device description and intended use clearly describe a chemical assay (FOBT) and its controls, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic control used to verify the performance of a fecal immunochemical test (FIT) for detecting human hemoglobin in stool, which indicates bleeding in the lower colon or rectum. It does not directly provide therapy or treatment to a patient.
No
The device, Enterix InSure FIT FOBT Controls, is a control solution used to verify the performance of a diagnostic test (Enterix InSure FIT product), but it is not itself a diagnostic device. It does not directly diagnose any condition; instead, it ensures the accuracy of another diagnostic tool.
No
The device description explicitly states it is an "aqueous control solution" packaged in "plastic bottles with dropper tips," indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states, "Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only..." This is a clear declaration of its intended purpose.
- Function: The device is a control used to verify the functionality and performance of another IVD device (Enterix InSure FIT product). Controls are essential components of the quality assurance process for IVD tests.
- Nature of the Test: The device is used in the context of a test that detects human hemoglobin in stool, which is a biological sample. This is a classic example of an in vitro diagnostic test.
- User and Setting: The intended users are "laboratories and other professional medical institutions," which are typical settings where IVD tests are performed.
Therefore, based on the provided information, the Enterix InSure FIT FOBT Controls clearly fall under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
Product codes
OSL
Device Description
Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips.
Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.
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
laboratories and other professional medical institutions
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
Non-clinical tests were conducted to verify specific performance requirements:
- Closed bottle stability (Shelf-life)
- Stability after opening (Use-life)
- Transport Stability
- Test response
No clinical tests were submitted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Juality Solutions
510(k) Summary1
K10/831
2010 OCT 1
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Minna Rannikko Director, R&D (978) 772-7070 x 236
28 September 2010
Date of preparation of this summary:
- (2) Device trade or proprietary name: Enterix® InSure® FIT™ FOBT Controls
Device common or usual name or classification name:
GGM Hematology Quality Control Mixture Sub class: OSL, Control Fecal Occult Blood
| REGULATION MEDICAL | REGULATION | CLASS | REGULATION |
|---|---|---|---|
| SPECIALTY | NUMBER | DESCRIPTION | |
| Hematology | 864.6550 | II | Occult Blood Test |
1. Substantial Equivalence
Enterix InSure FIT FOBT Control Solution is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use as shown in the following tables. Clearview Ultra FOB Kit and Hemoccult ICT FOB Test Kits were qualified per manufacturer's instructions using respective positive and negative controls.
| Product | Enterix InSure FIT FOBT
Negative Control | Clearview® Ultra FOB
Negative Control | Hemoccult® ICT FOB
Negative Control |
|-------------------------------------|---------------------------------------------|------------------------------------------|----------------------------------------|
| 510(k), Date | K101831, tbd | K041297, 12 Aug 2004 | K080812, 25 Jun 2008 |
| Net Fill | 1.5 mL | 1.0 mL | 0.8 ml |
| Analyte | hemoglobin | hemoglobin | hemoglobin |
| Hemoglobin
Concentration | zero | zero | zero |
| Container | 3 mL plastic dropper vial | 3 mL plastic dropper vial | 3 mL plastic dropper vial |
| Matrix | aqueous | aqueous | aqueous |
| Result on Enterix
InSure FIT Kit | Negative test line
Positive control line | --- | --- |
Table5.1: Comparison of Features - Negative Controls
ENTERIX and INSURE are registered trademarks of Enterix, Inc., Fernwood, NJ, USA.
CLEARVIEW is a registered trademark of Inverness Medical Switzerland GmbH, Zug Switzerland.
HEMOCCULT is a registered trademark of Beckman Coulter, Inc., Brea, CA, USA.
4 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
| Product | Enterix InSure FIT FOBT
Positive Control | Clearview Ultra FOB
Positive Control | Hemoccult ICT FOB
Positive Control |
|-------------------------------------|---------------------------------------------|-----------------------------------------|---------------------------------------|
| 510(k), Date | K101831, tbd | K041297, 12 Aug 2004 | K080812, 25 Jun 2008 |
| Net Fill | 1.5 mL | 1.0 mL | 0.8 ml |
| Analyte | hemoglobin | hemoglobin | hemoglobin |
| Container | 3 mL plastic dropper vial | 3 mL plastic dropper vial | 3 mL plastic dropper vial |
| Matrix | aqueous | aqueous | aqueous |
| Result on Enterix
InSure FIT Kit | Positive test line
Positive control line | | |
Table5.2: Comparison of Features - Positive Controls
II. Description of the new device
Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips.
Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.
(a) (1) Intended use of the device
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
(a) (2) Technological characteristics of the device.
This material consists of aqueous control solution prepared at two concentrations of hemoglobin and has been optimized to simulate the response of fecal occult blood samples on the Enterix InSure FIT Product. The solution contains bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.
Summary of non-clinical tests submitted with the premarket notification for the device. (b) (1) Tests were conducted to verify specific performance requirements:
- Closed bottle stability (Shelf-life) a)
- b) Stability after opening (Use-life)
- c) Transport Stability
- d) Test response
2
(b) (2) Summary of clinical tests submitted with the premarket notification for the device. N/A
Conclusions drawn from the clinical and non-clinical trials. (b) (3) Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Bionostics, Inc. c/o Ms. Minna Rannikko Director, Research and Development 7 Jackson Road Devens, MA 01434
OCT 01 2010
Re: K101831
Trade/Device Name: Enterix® Insure® FIT™ FOB Controls Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: OSL Dated: August 18, 2010 Received: August 24, 2010
Dear Ms. Rannikko:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of
4
Page 2 - Ms. Minna Ranniko
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Maria M. Chan, Ph.D
Par
. .
:
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enclosure
..
5
Indications for Use
510(k) Number: K101831
Device Name: Enterix® InSure® FIT™ FOBT Controls
Indications for Use:
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division Sign-On
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K101831
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