← Product Code [KHE](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE) · K063693

# FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST (K063693)

_New Bay Bioresearch Co. , Ltd. · KHE · May 11, 2007 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K063693

## Device Facts

- **Applicant:** New Bay Bioresearch Co. , Ltd.
- **Product Code:** [KHE](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE.md)
- **Decision Date:** May 11, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6550
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in the dication of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

## Device Story

Lateral flow immunochromatographic assay; detects human hemoglobin in fecal samples. Employs sandwich colloidal gold conjugate immunoassay with monoclonal antibodies. Sample flows through absorbent device; gold-labeled antibody-conjugate binds hemoglobin; complex binds to anti-hemoglobin antibody in reaction zone. Produces pink-rose color band at hemoglobin concentrations ≥50 ng/ml. Control zone confirms reagent function. Visually read by healthcare provider or user. Results aid in clinical assessment of gastrointestinal bleeding.

## Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of analytical properties to predicate device.

## Technological Characteristics

Lateral flow immunochromatographic assay; colloidal gold conjugate; monoclonal antibody-based detection. Qualitative, visually-read, single-use card format. Analytical sensitivity: 50 ng/ml. No electronic components or software.

## Regulatory 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

- WHPM Hemosure One Step Fecal Occult Blood (FOB) Test ([K041202](/device/K041202.md))

## Submission Summary (Full Text)

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K063693 MAY 11 2007

510(k) Submission For

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test

New Bay Bioresearch Co., Ltd.

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**510(k) Number:** Designed (k) Number to be Determined

## Submitter:

Tianjin New Bay Bioresearch Co., Ltd.

#3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District,

Tianjin, China

Telephone: 86-22-28751515

Facsimile: 86-222-875-1516

## Contact Person:

Rodrigo Berlie

New Product Development Director

Telephone: (760) 828-0990

Facsimile: (760) 602-2999

## Preparation Date:

December 08, 2006

## Device Information:

Trade or Proprietary Name:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test

Common/Usual Name:

Lateral flow immunochromatographic assay for detection of human hemoglobin or fecal occult blood in feces

Device Classification Name:

Immunoassay of human hemoglobin or fecal occult blood

Regulatory Name:

Human Hemoglobin or Fecal Occult Blood (FOB) Test System

Regulation Section: 21 CFR § 866.6550

Regulatory Class: Class II

Product Code: KHE

CONFIDENTIAL

{1}

510(k) Submission For
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test
New Bay Bioresearch Co., Ltd.

Panel: Hematology (81)

## Predicate Devices:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test cleared by FDA (K041202) for its stated intended use.

## Device Description:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, sandwich colloidal gold conjugate immunoassay for the determination of human hemoglobin in feces. The method employs a unique combination of monoclonal antibodies to selectively identify hemoglobin in test sample with a high degree of sensitivity. In less than 5 minutes, elevated levels of human hemoglobin as low as 50 ng/ml can be detected, and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to another anti-hemoglobin antibody in the positive reaction zone and produces a pink-ross color band when hemoglobin concentration is greater than 50 ng/ml. In the absence of hemoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative control zone. Unbind conjugate binds to the reagents in the negative control zone, producing a pink rose color band, demonstrating that the reagents and device are functioning correctly.

A NEGATIVE specimen produces one distinct color bands in control area. A POSITIVE specimen produces two color bands in the control and test area. There is no meaning attributed to color or its intensity for either line.

## Intended Use:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in the dication of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

## Comparison to Predicate Device(s):

Both devices (Forsure and WHPM) are for the qualitative determination of the Fecal Occult Blood. The specific antibodies against human hemoglobin were used in both devices. All test devices are visually-read single use device. The cutoff of each analyte is same (50 ng/ml or 50 µg/g of feces).

CONFIDENTIAL

{2}

510(k) Submission For
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test
New Bay Bioresearch Co., Ltd.

## Summary:

The information provided in this pre-market notification demonstrates that Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is safe and effective for its stated intended use.

CONFIDENTIAL
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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K063693](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K063693)

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