hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Device Description

hema-screen ER XCEL™ in its original concept as slides and tape was designed to offer the hospital, mass screening programs and clinical laboratories a convenient rapid method for handling fecal specimens in testing for occult blood. hema-screen ER XCEL™ is especially useful for mass screening programs as its enhanced readability feature facilitates the technicians' ability to make a determination.

hema-screen ER XCEL™ eliminates the mess and odors associated with the collection and transport of fecal specimens. Slides can be prepared at the patient's bedside and placed in a sealed envelope or by the patient at home and mailed to the hospital or laboratory in an inoffensive manner for development and evaluation.

hema-screen ER XCEL™ single slides are convenient for use when single stool specimens are to be tested. A single test is indicated when blood loss in the gastrointestinal tract is strongly suspected, for example, in persons with symptoms of ulcers, anemia, black stools or postoperative patients.

hema-screen ER XCEL™ Enhanced Readability Patient Packs are to be utilized so the patient can serially collect specimens at home over the course of three bowel movements. Patients should be instructed to follow the directions exactly, as the potential for false positive results exists due to improper diet, blood on the hands, hemorrhoids or if the test is used during menstrual bleeding. After all three slides are prepared, the slides may be sent back to the hospital laboratory for developing and evaluation. Preparation of three consecutive slides is recommended for screening asymptomatic patients by the American Cancer Society.

When stool specimens containing occult blood are applied hema-screen ER XCEL™ test paper, the hemoglobin portion of the occult blood comes in contact with the guaiac. When the hema-screen ER XCEL™ peroxide developing solution is added, a guaiac-peroxidase like reaction occurs. The chemical reaction becomes visible by the appearance of a blue-green color between 30 seconds and 60 seconds if occur blood is present.

AI/ML Overview

This document describes the hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test, which is a qualitative method for detecting occult blood in stool. The application is a 510(k) premarket notification claiming substantial equivalence to the predicate device hema-screen™ ER (K102664).

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The substantial equivalence claim is based on the assertion that the "fundamental scientific technology of the modified device has not changed" and "There is no change in analytical sensitivity of the new device." The changes primarily involve the addition of an optional patient sampling slide with a GRID design for enhanced readability and ease of use, rather than a change in the underlying diagnostic performance.
Sample Size Used for the Test Set and Data Provenance:

The document does not provide details on a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The application relies on demonstrating that the modified device's analytical sensitivity has not changed compared to the predicate device, which would imply that its performance characteristics are comparable.
Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number or qualifications of experts used to establish ground truth. As this is a 510(k) for a modification (addition of a GRID design for readability) to a previously cleared device, the focus is on maintaining existing performance rather than re-establishing ground truth for diagnostic accuracy with a new study.
Adjudication Method for the Test Set:

No adjudication method is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The device is a qualitative test for occult blood, not an AI-assisted diagnostic tool for human readers.
Standalone Performance Study:

The document does not describe a standalone (algorithm only) performance study as this is not an AI/algorithm-based device. The device itself is a qualitative chemical test. The "enhanced readability" feature refers to the physical design of the sampling slide.
Type of Ground Truth Used:

The document implies that the ground truth for establishing the performance of the original predicate device (and by extension for demonstrating no change in the modified device) would be related to the presence or absence of occult blood, likely confirmed by established clinical methods or laboratory techniques. However, specific details on how this ground truth was used or established are not provided in this summary.
Sample Size for the Training Set:

The document does not mention a training set sample size, as this is a chemical diagnostic test and not a machine learning or AI-based device that would typically involve a training set.
How Ground Truth for the Training Set Was Established:

Not applicable, as no training set is described for this type of device.

Summary of Device Modification and Basis for Substantial Equivalence:

The primary change in the hema-screen ER XCEL™ device from its predicate (hema-screen™ ER) is the addition of an optional patient sampling slide with a GRID design. The manufacturer states:

"The fundamental scientific technology of the modified device has not changed."
"The internal guaiac paper has neither been modified nor reformulated."
"There is no change in analytical sensitivity of the new device."
The modified design simply features a smaller surface area (small circles) on the outer cardboard to help prevent oversampling and ease of use for the patient, which facilitates readability for technicians.

Therefore, the application argues for substantial equivalence based on the technological characteristics being identical for the core diagnostic mechanism and that the design change related to readability does not impact the scientific principle, materials, intended use, operating principle, basic design, shelf life, or enhanced developing solution. The risk analysis indicated that the modifications were satisfactory and did not raise new issues of safety or effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 17, 2017

Immunostics, Inc. Antoinette Prusik Director Regulatory Affairs 1750 Brielle Ave. Suite A5 Ocean, New Jersey 07712

Re: K163554

Trade/Device Name: hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: December 15, 2016 Received: December 19, 2016

Dear Ms. Prusik:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163554

Device Name

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test

Indications for Use (Describe)

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive nualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Special 510(k) Summary

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR, Section 807.92.

Date Summary prepared: December 15th 2016

Regulatory Correspondent

Immunostics, Inc. 1750 Brielle Ave Ste A5 Ocean, New Jersey 07712 Phone No .: (732) 918-0770 Fax No .: (732) 918-0618 Contact: Antoinette Prusik E-mail: aprusik@immunostics.com Website: www.immunostics.com Establishment Registration Number: 2244821

Device Information

Trade Name: hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test Common Name: Reagent, Occult Blood Regulation Name: Occult Blood Test Product Code: KHE

Regulation: 21 CFR § 864.6550

Predicate Device: hema-screen™ ER Predicate 510(k) Number: K102664

Intended Use/Indications for Use(s):

hema-screen ER XCEL™ is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Image /page/3/Picture/14 description: The image shows the logo for Immunostics, Inc. The logo is in gray and features a stylized sunburst to the left of the text. The text "immunostics, inc." is written in a serif font, with small circles above the "o" in "immunostics" and the "i" in "inc."

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Image /page/4/Picture/1 description: The image shows a red and white sign with a lowercase "i" in the center. The "i" is red and outlined in white, and it is set against a white background. The sign is rectangular in shape and has a red border. The sign appears to be glossy, as if it is made of plastic or glass.

Device Description: Subject Device

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test

Principles of Test

Image /page/4/Picture/10 description: The image shows the logo for Immunostics, Inc. The logo is in gray and features a stylized sunburst to the left of the word "Immunostics, inc." The font is a serif typeface, and the overall design is simple and professional.

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Image /page/5/Picture/1 description: The image shows a red and white sign with the letter 'i' on it. The 'i' is white and is inside a red rectangle. The rectangle has a white border around it. The sign is likely used to provide information or directions.

Substantial Equivalence Information

Characteristic	Proposed Devicehema-screen ER XCELTMEnhanced Readability	Predicate DeviceK102664hema-screenTM ER
IntendedUse/Indicationsfor Use	hema-screen ER XCELTM is arapid, convenient, and non-offensive qualitative method fordetecting occult blood in thestool. It is intended forprofessional use as an aid in thediagnosis of asymptomaticgastrointestinal conditions thatmay manifest themselves by thepresence of occult blood in thestool. This test is recommendedfor use in routine hospitaltesting, mass screeningprograms for colorectal cancer,and in testing of postoperativepatients and newborn infants.	Same
MaterialsProvided	hema-screen ER XCELTMSlides -A specialelectrophoresis paperimpregnated with natural guaiacresin. Contains both positive (+)and negative (-) performancestandards. The positive (+)standard contains a hemoglobinderived catalyst on the slide.hema-screen ER XCELTMDeveloping Solution (enhanced)– Contains a stabilized mixtureof hydrogen peroxide (less than6%) and (75% denatured ethylalcohol with additives inaqueous solution.hema-screen ER XCELTMLaboratory Pack_- Instructionsfor use, 100 single slides withPerformance Standards. two (2)	Same
10 ml bottles of DevelopingSolution, and 100 applicatorsticks. Also available in 50pack.

Image /page/5/Picture/4 description: The image shows the logo for Immunostics, Inc. The logo is in gray and features a stylized starburst to the left of the word "Immunostics". The word "Inc." is in a smaller font and is located to the right of the word "Immunostics".

1750 Brielle Ave. • A5 • Ocean, New Jersey • 07712 2nollow 1100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Technological Characteristics:

The fundamental scientific technology of the modified device has not changed. The change is for the addition of an optional patient sampling slide with GRID: the internal guaiac paper has neither been modified nor reformulated; the outer cardboard contains smaller surface area (small circles) to help prevent oversampling and ease of use for the patient.

There is no change in analytical sensitivity of the new device.

The intended use/indication use of the modified device as described in the labeling has not changed.

Name change to hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test. Both patient sampling slide versions (GRID and Non-GRID) are available and optional in hemascreen ER XCEL™ Enhanced Readability Fecal Occult Blood Test.

Substantial Equivalence:

Similarities
Subject Device	Predicate Device K102664
Intended Use	Intended Use
Operating Principal	Operating Principal
Materials	Materials
Basic Design	Basic Design
Shelf Life	Shelf Life
Enhanced DevelopingSolution	Enhanced DevelopingSolution

Differences

Item	Subject Devicehema-screen ER XCELTMEnhanced ReadabilityFecal Occult Blood Test	Predicatehema-screenTM ERK102664
Design	Both patient sampling slideversions (GRID and non-GRID) areavailable and optional.	Only the non-GRID version
Materials Provided	hema-screen ER XCELTM PatientPack - Instructions for use, 50	hema-screenTM ER Patient Pack -Instructions for use, 150 patient

Image /page/6/Picture/12 description: The image shows the logo for Immunostics, Inc. The logo features a stylized starburst to the left of the text "immunostics, inc.". The text is in a serif font and is a light gray color. The overall design is simple and professional.

0 Brielle Ave. · A5 · Ocean, New Jersey · 07712 (800) 722-7505 · Fax: (732) 918-0618 www.lmmunostics.com

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Image /page/7/Picture/0 description: The image shows a red and white icon. The icon is a red letter "i" inside of a white rectangle with a red border. The letter "i" has a circle above it, similar to a lowercase "i". The background is a gradient of red and white.

Item	Subject Devicehema-screen ER XCEL™Enhanced ReadabilityFecal Occult Blood Test	Predicatehema-screen™ ERK102664
	patient slides with a GRID designfor easy readability. PerformanceStandards, three 10mL bottles ofDeveloping Solution, 150applicator sticks, patientinstructions and 50 foil-linedmailing pouches.	slides without a GRID withPerformance Standards, three 10mLbottles of Developing Solution, 150applicator sticks, patientinstructions and 50 foil-linedmailing pouches.

Design Control Activities Conducted:

A Risk Analysis was used to assess the impact of the modifications on the device and its components, and the results of the analysis.

Based on the Risk Analysis, an identification of the verification and/or validation required, including methods or tests used and acceptance criteria was applied and found to be satisfactory. A Declaration of Conformity statement with design controls is presented.

Conclusion Drawn:

The hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is as safe and effective as the predicate device, hema-screen TM ER.

The hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test has the same intended use and indications for use and fundamental scientific technology.

The difference between the subject device, hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test and predicate device, hema-screen" ER (addition of an optional GRID design version of the hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test) raises no new issues of safety and effectiveness.

The hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is substantially equivalent to the predicate device.

Image /page/7/Picture/11 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst symbol to the left of the text "immunostics, inc.". The text is in a serif font and is a light gray color.

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.