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.

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.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Enterix® InSure® FIT™ FOBT Controls, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the device as a quality control solution for the Enterix InSure FIT product. Its primary function is to verify the performance of the InSure FIT test. Therefore, the acceptance criteria are directly tied to how the control solutions behave when tested with the InSure FIT Kit.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Requirement	Reported Device Performance (Enterix InSure FIT FOBT Controls)
Negative Control Performance	When tested with the Enterix® InSure® FIT™ Kit, the Negative Control must yield a "Negative test line" and a "Positive control line."
Positive Control Performance	When tested with the Enterix® InSure® FIT™ Kit, the Positive Control must yield a "Positive test line" and a "Positive control line."
Closed bottle stability (Shelf-life)	Tests were conducted to verify this specific performance requirement. (Specific duration or criteria not detailed in this summary, but the study was performed).
Stability after opening (Use-life)	Tests were conducted to verify this specific performance requirement. (Specific duration or criteria not detailed in this summary, but the study was performed).
Transport Stability	Tests were conducted to verify this specific performance requirement. (Specific conditions or criteria not detailed in this summary, but the study was performed).
Test response	The control solution contains bovine albumin, salts, buffers, preservatives, and (for the positive control) human hemoglobin, optimized to simulate the response of fecal occult blood samples on the Enterix InSure FIT Product. Tests were conducted to verify test response.

Study Information

The provided document is a 510(k) summary for a control solution, not the primary diagnostic test itself. Therefore, the studies primarily focus on the performance and stability of the control solution rather than extensive clinical validation of a diagnostic algorithm.

Sample size used for the test set and the data provenance:
- The document does not specify explicit sample sizes (e.g., number of runs, number of vials) for the stability or test response studies. It only states that "Tests were conducted to verify specific performance requirements."
- Data Provenance: Not specified as being from a particular country. These are likely internal laboratory studies conducted by Bionostics, Inc. The studies are non-clinical tests as explicitly stated ("Summary of non-clinical tests submitted with the premarket notification for the device.").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this submission. The "ground truth" for a control solution's performance is its expected reactivity with the intended diagnostic kit (e.g., negative control should be negative, positive control should be positive). The evaluation of these controls would be based on the instrument/kit's reading, not expert interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The evaluation of control solution performance on an in vitro diagnostic test typically involves observing the expected reaction (e.g., appearance of a line) on the test strip, rather than expert adjudication of complex clinical images or diagnoses.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done (or is applicable). This device is a control solution for an IVD kit, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a control solution for an in vitro diagnostic test, not an algorithm or AI device. The "performance" is whether the control solution produces the expected result on the test kit.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is intrinsic to the design of the control solutions:
  - Negative Control: Designed to lack human hemoglobin, thus expected to yield a negative result on the InSure FIT test.
  - Positive Control: Designed to contain stabilized human hemoglobin, thus expected to yield a positive result on the InSure FIT test.
- The verification of this ground truth is done by testing the controls with the InSure FIT Kit and observing the qualitative outcome (presence/absence of test lines, presence of control line).
The sample size for the training set:
- Not applicable for this type of device (control solution). There is no "training set" in the context of machine learning or AI models. The controls are manufactured to specified formulations.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the performance of the control solutions is established by their intended chemical composition and expected reactivity with the InSure FIT test.

Summary

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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 FOBTNegative Control	Clearview® Ultra FOBNegative Control	Hemoccult® ICT FOBNegative 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
HemoglobinConcentration	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 EnterixInSure FIT Kit	Negative test linePositive 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.

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Product	Enterix InSure FIT FOBTPositive Control	Clearview Ultra FOBPositive Control	Hemoccult ICT FOBPositive 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 EnterixInSure FIT Kit	Positive test linePositive control line

Table5.2: Comparison of Features - Positive Controls

II. Description of the new device

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

(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

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(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.

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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

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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

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Indications for Use

510(k) Number: K101831

Device Name: Enterix® InSure® FIT™ FOBT Controls

Indications for Use:

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

Page 1 of 1

Regulation Number and Section

§ 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.