hema-screen SPECIFIC Gold

K171484 · Immunostics Inc., · KHE · Jun 14, 2017 · Hematology

Device Facts

• Record ID: K171484
• Device Name: hema-screen SPECIFIC Gold
• Applicant: Immunostics Inc.,
• Product Code: KHE · Hematology
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Device Story

hema-screen™ SPECIFIC Gold; immunochemical fecal occult blood test (iFOBT) for detection of gastrointestinal bleeding; modified version of hema-screen™ SPECIFIC (K060463). Modification involves name change and slimmer test cassette housing design. Device utilizes immunochemical assay methods to detect human hemoglobin in fecal samples. Intended for use by healthcare professionals to aid in identifying gastrointestinal pathology. Performance verified via FMEA risk analysis and comparative testing against predicate; results confirm equivalent safety and effectiveness.

Clinical Evidence

Bench testing only. Comparison of three lots of subject device against predicate device showed 100% agreement, 100% positive percent agreement, and 100% negative percent agreement. Results met acceptance criteria of >98% total agreement.

Technological Characteristics

Lateral flow immunoassay; sandwich dye conjugate; monoclonal antibodies; qualitative visual readout. Housing is a slimmer plastic design compared to predicate. No changes to lateral flow membrane material or chemical composition. Standalone device; no energy source required.

Indications for Use

Indicated for the qualitative detection of fecal occult blood, an indicator of gastrointestinal bleeding, in fecal samples.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• hema-screen™ SPECIFIC (K060463)

Submission Summary (Full Text)

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

June 14, 2017

Immunostics, Inc. Elizabeth Galella Manager Regulatory Affairs 1750 Brielle Avenue Suite A5 Ocean, New Jersey 07712

Re: K171484

Trade/Device Name: hema-screen™ SPECIFIC Gold Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: May 19, 2017 Received: May 22, 2017

Dear Ms. Galella:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely.

# Leonthena R. Carrington -S

Lea 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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510(k)No.: unknown

### Indications for Use Statement

| Device Name: | hema-screen ^TM SPECIFIC Gold |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Hema-Screen ^TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source. |
| Prescription Use | <u>XX</u> AND/OR Over the Counter Use _______ |
| | (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C) |

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/2/Picture/7 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst to the left of the company name. The text is in a serif font and appears to be gray.

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Duality Microbiological, Serological and Immunological Reagents

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# SPECIAL 510(k) SUMMARY

### hema-screen™ SPECIFIC Gold

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: May 19, 2017

### Regulatory Correspondent

Immunostics, Inc. 1750 Brielle Ave, Suite A5 Ocean, NJ 07712 USA Phone: [phone] Fax: [phone] Contact: Elizabeth Galella Email: [e-mail] Website: www.immunostics.com Establishment registration Number: 2244821

### Device Information

Trade Name: hema-screen™ SPECIFIC Gold Common Name: Fecal Immunochemical Test

Classification Name: Reagent, Occult Blood Product Code: KHE Regulation: 21 CFR § 864.6550

Predicate Device: hema-screen™ SPECIFIC Predicate 510(k) Number: K060463

### Device Description: Subject Device hema-screen™ SPECIFIC Gold

### Intended Use/Indication for Use:

The hema-screen™ SPECIFIC Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Image /page/3/Picture/15 description: The image shows the logo for "Immunostics, inc.". The logo features a stylized starburst to the left of the text. The text is in a serif font and is gray in color. The logo is simple and clean, and it is likely used to represent the company's brand.

1750 Brielle Ave. · A5 · Ocean, New Jersey · 07712 [phone] · Fax: [phone] www.lmmunostics.com

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# Quality Microbiological, Serological and Immunological Reagents

Image /page/4/Picture/1 description: The image shows a red and white icon. The icon is a red rectangle with a white background. Inside the rectangle is a red letter "i" with a circle on top. The icon is simple and eye-catching.

## SPECIAL 510(k) SUMMARY

### Principles of Test

hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.

### Technological Characteristics:

The fundamental scientific technology of the subject device has not changed. The design, material and chemical composition of the lateral flow membrane has not changed. There is no change in analytical sensitivity of the subject device.

The change is for new housing for the lateral flow membrane.

### Summary of Patient Fecal Sample Testing:

Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate, 100% positive percent agreement with the predicate and 100% negative percent with the predicate. The testing results meet the acceptance criteria (greater than 98% total, PPA, NPA) for the study.

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# SPECIAL 510(k) SUMMARY

### Substantial Equivalence

### Similarities

| Item | Subject Device K171484<br>hema-screen™ SPECIFIC Gold | Predicate Device K060463<br>hema-screen™ SPECIFIC |
|---------------------------------------------|------------------------------------------------------|---------------------------------------------------|
| Intended Use/Indications for Use | Same | Same |
| Operating Principle (Principles of<br>Test) | Same | Same |
| Technological Characteristics | Same | Same |
| Shelf Life | Same | Same |
| Performance Characteristics | Same | Same |

### Differences

| Item | Subject Device K171484<br>hema-screen™ SPECIFIC Gold hema-screen™ SPECIFIC | Predicate Device K060463 |
|-------------------|------------------------------------------------------------------------------|----------------------------|
| Design of Housing | Slimmer housing design | Rectangular housing design |

### Conclusion Drawn:

The subject, hema-screen™ SPECIFIC Gold, and predicate, hema-screen™ SPECIFIC, have the same Intended Use/Indications for Use Statement, Principles for Test, Technological Characteristics, Shelf Life and Performance Characteristics.

The only difference between the subject, hema-screen™ SPECIFIC Gold, and predicate, hemascreen™ SPECIFIC is the housing. The lateral flow membrane is the same. The housing change between the subject hema-screen™ SPECIFIC Gold and the predicate hema-screen™ SPECIFIC raises no new issues of safety and effectiveness.

The subject, hema-screen™ SPECIFIC Gold, is as safe, as effective and as performs as well as the predicate, hema-screen™ SPECIFIC.

The subject, hema-screen™ SPECIFIC Gold, is substantially equivalent to the predicate, hemascreen™ SPECIFIC.

Image /page/5/Picture/13 description: The image shows the logo for Immunostics, Inc. The logo is in a stylized font and features a starburst design to the left of the word "Immunostics". The letters are in gray and the word "inc." is in a smaller font size.