The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.

Device Description

The Innovacon Flipcard™ Fecal Occult Blood Test Device is a rapid test intended for the qualitative detection of low levels Fecal Occult Blood. The test uses monoclonal antibodies to selectively detect human hemoglobin in fecal samples The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50 ng hHb/mL buffer or 300 ug hHB/g feces. The FOB One Step Fecal Occult Blood Test does not require the patient to follow any special dietary restrictions.

AI/ML Overview

Acceptance Criteria and Study for Innovacon Flipcard™ Fecal Occult Blood Test Device

This device, the Innovacon Flipcard™ Fecal Occult Blood Test Device, is a rapid qualitative test for human hemoglobin in fecal samples, intended as a screening tool for lower gastrointestinal bleeding. The study performed aims to demonstrate substantial equivalence to a predicate device, the Hemoccult® ICT Immunological Fecal Occult Blood Test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, particularly regarding accuracy (positive, negative, and overall agreement). There are no explicitly stated numerical acceptance criteria for agreement percentages in the provided text. However, the reported performance demonstrates high agreement with the predicate device.

Performance Metric	Acceptance Criteria (Implicit - High Agreement with Predicate)	Reported Device Performance (Innovacon Flipcard™ vs. Hemoccult® ICT)
Part A: Sample Collection from Study Participants
Positive Agreement	High Agreement	100% (2/2)
Negative Agreement	High Agreement	99.1% (115/116) (95.3%-100%, 95% CI)
Overall Agreement	High Agreement	99.2% (117/118) (95.4%-100%, 95% CI)
Part B: Laboratory Study by Professionals
Positive Agreement	High Agreement	95.8% (46/48) (85.7%-100%, 95% CI)
Negative Agreement	High Agreement	98.0% (100/102) (93.1%-99.8%, 95% CI)
Overall Agreement	High Agreement	97.3% (146/150) (93.3%-99.3%, 95% CI)

2. Sample Size and Data Provenance

Sample Size for Test Set:
- Part A (Sample Collection from Study Participants): 118 samples (2 positive, 116 negative based on agreement numbers).
- Part B (Laboratory Study by Professionals): 150 samples (48 positive, 102 negative based on agreement numbers).
- The document also states "A clinical evaluation was conducted using a total of 120 clinical specimens" but the sum of samples for Part A and Part B (118+150 = 268) is significantly higher. It's possible that the "120 clinical specimens" refers to a subset or a different overarching study, and the detailed breakdown for Part A and Part B are distinct analyses within larger datasets.
Data Provenance: The document does not explicitly state the country of origin for the data. The study involved "clinical specimens," suggesting a prospective collection for the purpose of the evaluation, but it doesn't explicitly state "prospective" or "retrospective." Given the mention of "clinical evaluation," it implies real-world samples were used.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. The "ground truth" for this study is the result obtained from the predicate device, Hemoccult® ICT.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The comparison is made directly between the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device against a predicate device, not in the context of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone comparison was done. The study's "Accuracy" section describes the Innovacon Flipcard™ Fecal Occult Blood Test Device's performance directly against the predicate device, Hemoccult® ICT, without the explicit involvement of human readers interpreting results from both. The results for "Part A: Sample Collection from Study Participants" and "Part B: Laboratory Study by Professionals" represent the device's performance in detecting fecal occult blood.

7. Type of Ground Truth Used

The "ground truth" used in this study is the result obtained from the predicate device, Hemoccult® ICT Immunological Fecal Occult Blood Test. The study design is a comparison of the new device's performance against an already legally marketed and established device, rather than against an absolute gold standard like pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This device is a rapid diagnostic kit, rather than a machine learning algorithm that typically requires a distinct training phase. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the method for establishing its ground truth is not provided and is not applicable to this type of device submission.

Summary

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10. SUMMARY OF 510(k)

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is K063673_______________________________________________________________________________________________________________________________

Submitter:

Innovacon, Inc. 4106 Sorrento Valley Boulevard San Diego, California 92121 Tel.: 858-535-2030 Fax: 858-535-2038

Establishment Registration Number: 3005689981 Owner/Operator Number: 9006731

Date:

11/20/06

Contact Person:

Edward Tung, Ph.D.

Product Name:

Innovacon Flipcard™ Fecal Occult Blood Test Device

Common Name:

Fecal Occult Blood Rapid Test

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Classification Information:

The Innovacon Flipcard™ Fecal Occult Blood Test Device is similar to other FDAcleared devices for the qualitative detection of lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer.

Classification:	Class II
Regulation Number:	864.6550
Product Code:	KHE
Classification Name:	Reagent Occult Blood
Complexity:	Waived
Analyte:	Fecal Occult Blood
Test Category:	Manual procedures with limited steps and limited sample and reagent preparation

Intended Use:

Description:

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Comparison to Predicate Devices:

A summary of comparison of the features of the Innovacon Flipcard™ Fecal Occult Blood Test Device, and the predicate device is shown below:

Immunological Fecal Occult Blood Test
	Innovacon FlipcardTM	Hemoccult® ICT
	Fecal Occult Blood Test	Immunological Fecal
Feature	Device	Occult Blood Test
Indicationfor use	A lateral-flow immunoassay intendedfor the qualitative detection of humanhemoglobin in fecal samples	A rapid visually read qualitativeimmunochemical chromatographicmethod for detection of humanhemoglobin in fecal samples.
Intended Use	Professional	Professional
Intended specimen	Fecal	Fecal
Endpoint	Colored Lines	Colored Lines
Materials provided	Flushable Collection TissuesCollection CardsCollection SticksProtective PouchesMailing EnvelopesKit Bags w/Patient InstructionsFOB Test DevicesBufferPositive ControlNegative ControlPackage insertProcedure card	Test devicesBufferPackage Insert
Methodology	Membrane particle assay	Membrane particle assay
Test Time	5 minutes	5 minutes
Format	Antigen/antibody immunoassay	Antigen/antibody immunoassay

Innovacon Flipcard™ Fecal Occult Blood Test Device versus Table 2. Hemoccult® ICT Immunological Fecal Occult Blood Test

Accuracy

A clinical evaluation was conducted using a total of 120 clinical specimens. The detection of human occult blood in clinical fecal specimens was done by using the Innovacon Fecal™ Occult Blood Test Device and Predicate Device, Hemoccult® ICT Immunological Fecal Occult Blood Test

Innovacon Flipcard™ Fecal Occult Blood Test Device compared to Hemoccult® ICT Immunological Fecal Occult Blood Test

Part A Sample Collection from Study Participants

Positive Agreement=2/2 = 100% Negative Agreement = 115/116 =99.1% (95.3%-100%, 95% CI) Overall Agreement = 117/118 = 99.2% (95.4%-100%, 95% CI)

Part B Laboratory Study by Professionals

Positive Agreement=46/48 = 95.8% (85.7%-100%, 95% CI) Negative Agreement = 100/102 =98.0% (93.1%-99.8%, 95% CI) Overall Agreement = 146/150 = 97.3% (93.3%-99.3%, 95% CI)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INNOVACON, INC. C/O Edward Tung 4106 Sorrento Valley Blvd. San Diego, California 92121

MAR 0 5 2007

Re: K063673

Trade/Device Name: Innovacon Flipcard™ Fecal Occult Blood Test Device Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: December 6, 2006 Received: December 11, 2006

Dear Dr. Tung:

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 either class II (Special Controls) or class III (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Beetal

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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9. INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Innovacon Flipcard™ Fecal Occult Blood Test Device

1063673

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sign-Off

f Very Device

510(k) K063673 11

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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.