IMMOCARE

K052598 · Care Diagnostic, Inc. · KHE · Mar 16, 2006 · Hematology

Device Facts

• Record ID: K052598
• Device Name: IMMOCARE
• Applicant: Care Diagnostic, Inc.
• Product Code: KHE · Hematology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ImmoCARE® 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 indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

Device Story

ImmoCARE® is a rapid immunochromatographic assay for qualitative detection of human hemoglobin in fecal samples. Device functions as a diagnostic aid for gastrointestinal bleeding associated with conditions like colorectal carcinoma, Crohn's disease, ulcerative colitis, and polyps. Used by healthcare professionals or patients (OTC); provides visual qualitative results. Benefits include convenient, hygienic screening for occult blood to facilitate early clinical investigation of GI pathology.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunochromatographic lateral flow assay. Components: sampling bottle with extraction buffer, test cassette with membrane. Detection: anti-β-hHb monoclonal antibody-colloidal gold conjugate. Internal control: rabbit IgG/goat anti-rabbit IgG. Cut-off: 0.03 mg hHb/g stool. Standalone, non-electronic, visual readout.

Indications for Use

Indicated for qualitative detection of intact human hemoglobin in fecal specimens to identify fecal occult blood in humans. Used as an aid in detecting gastrointestinal diseases associated with bleeding, including colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps. Suitable for both professional and over-the-counter use.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K052598

B. Purpose for Submission:
Marketing in the US

C. Measurand:
Human Hemoglobin

D. Type of Test:
Immunological test for the qualitative detection of monoclonal antibodies for human hemoglobin

E. Applicant:
Care Diagnostic, Inc.

F. Proprietary and Established Names:
ImmoCARE Fecal Occult Blood (FOB) Test

G. Regulatory Information:
1. Regulation section:
21 CFR § 866.6550
2. Classification:
Class II
3. Product code:
KHE, Reagent, Occult Blood
4. Panel:
Hematology 81

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H. Intended Use:

1. Intended use(s):

The ImmoCARE® 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 indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

2. Indication(s) for use:

ImmoCARE® is an immunological test for both professional and home-use.

3. Special conditions for use statement(s):

N/A

4. Special instrument requirements:

N/A

I. Device Description:

The ImmoCARE FOB test kit consists of sampling bottles containing an extraction buffer and the immunochromatographic test in cassettes.

J. Substantial Equivalence Information:

1. Predicate device name(s):

ColonCARE

Hemoccult guaiac test

2. Predicate 510(k) number(s):

K030216

K880499

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3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate K030216 | Predicate K880499 |
| Test Principle | Immunoassay utilizing MAbs for the detection of human hemoglobin | Immunoassay utilizing MAbs for the detection of human hemoglobin | |
| Sample | Feces in extraction buffer | Feces in extraction buffer | |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate K030216 | Predicate K880499 |
| Test Principle | Immunoassay utilizing MAbs for the detection of human hemoglobin | | Guaiac test |
| Sample | Feces in extraction buffer | | Feces on slide card |

K. Standard/Guidance Document Referenced (if applicable):
“Review Criteria for the Qualitative Assessment of Fecal Occult Blood In Vitro Diagnostic Devices”

L. Test Principle:

After application of the sample to the sample well, the sample (and if present, the hHb) migrates to a membrane coated with colloidal-antibody-gold-conjugates by capillary action. If hHb is present, it binds to the its binding partner, the anti-β-hHb monoclonal antibody-colloidal gold conjugate, forming a colored complex. The complex continues migrating to a line of immobilized anti-hHb antibody coated onto the results field in the form of a line (labeled “T” (Test line) on the cassette). As a result, a pink-rose color-line appears in the results field at the position of the “T”, if hHb is present.

As an internal quality control, the normal rabbit IgG colloidal-antibody-gold-conjugate coated in the membrane start migrating as well. This IgG colloidal antibody-gold conjugate will be captured in the results field via goat anti-(rabbit IgG) polyclonal antibody at the position labeled with “C” (Control Line) on the cassette

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forming a pink-rose Control Line independent of the whether hHb is present or not and therefore serves as a control for the correct testing procedure.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Reproducibility studies were conducted using human hemoglobin free stool extracts from 6 subjects. Samples were collected and separated in five groups of six for a total of 30 samples. Each group of specimens was spiked with a known level of human hemoglobin to result in the following concentrations; 0 mg/l, 1,370 mg/l, 137 mg/l, 13.7 mg/l and 1.37 mg/l. The results of the studies are presented in the table below.

Reproducibility studies for ImmoCARE

| | Test 1 | Test 2 | Test 3 | Test 4 | Test 5 | Test 6 |
| --- | --- | --- | --- | --- | --- | --- |
| 0 mg/l | - | - | - | - | - | - |
| 1370 mg/l | +++ | +++ | +++ | +++ | +++ | +++ |
| 137 mg/l | ++ | ++ | ++ | ++ | ++ | ++ |
| 13.7 mg/l | - | - | - | - | - | - |
| 1.37 mg/l | - | - | - | - | - | - |

#### b. Linearity/assay reportable range:

N/A

#### c. Traceability, Stability, Expected values (controls, calibrators, or methods):

**Internal Control:** Is built into the test strip and assures that the sample addition and migration through the test strip has occurred and that the control anti-mouse antibody and the reporter antibody are intact and functional.

**External Control:** Assures that the capture and conjugated antibodies are present and reactive. Positive and negative controls are available from CARE Diagnostics, Inc.

#### d. Detection limit:

The minimal detectable concentration of hHb is 0.05 µg/ml in buffer or 0.03 mg hHb/g stool.

#### e. Analytical specificity:

**Animal hemoglobins and tissues**

A performance study was completed to investigate the cross reactivity of other species of hemoglobin (Hb) and tissue extracts on the ImmoCARE FOB test. Hb of bovine, equine, pig, rabbit, sheep, chicken and origin was added to the

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test device to determine the cross reactivity of the test with Hb of other species. The results continued to be negative after the addition of each Hb species.

## Dietary substances

A performance study was completed to investigate the interference of dietary substances on the ImmoCARE FOB test. Raw cantaloupe, radish, horseradish, broccoli, cauliflower, parsnip, paprika, parsley, leak and turnip were added to the test device to determine if vegetable extracts cross react with the test. The extracts were prepared by homogenizing raw vegetable in a food processor. Dietary iron and Vitamin C supplements and were also tested for cross reactivity. The dietary substance extracts were added to normal stool extracts. The results continued to be negative after the addition of each dietary substance.

f. Assay cut-off:

N/A

2. Comparison studies:

a. Method comparison with predicate device:

Studies were performed comparing five different guaiac FOB tests, including the Hemoccult test. All of the examined FOB tests performed similarly.

b. Matrix comparison:

N/A

3. Clinical studies:

A clinical study was performed at a gastroenterology center on 253 patients (131 females and 122 males) between the ages of 19-88 years. The results of the predicate (Hemoccult guaiac test) and the ImmoCARE tests were compared to reference test (colonoscopy) results. The comparison is shown below:

| | Colonoscopy | ImmoCARE | Hemoccult |
| --- | --- | --- | --- |
| Normal | 158 | 186 Neg | 222 Neg |
| Results with Pathological findings | 95 | 67 Pos | 31 Pos |
| Total | 253 | 253 | 253 |

a. Clinical Sensitivity:

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The clinical sensitivity is 62.1% compared to Hemoccult’s 29.4% when compared to colonoscopy.

b. Clinical specificity:
The clinical specificity is 95% compared to Hemoccult’s 98% when compared to colonoscopy.

c. Other clinical supportive data (when a. and b. are not applicable):
A study on the interpretation of lay readers (N=83) from various educational backgrounds and over the age of 50 y.o. was also performed. When compared to expert readings, lay readers had agreement rates of 97.43% for positive tests, 95.6% for negative tests and 100% for invalid tests.

4. Clinical cut-off:
The cut-off was determined to be 0.03 mg hHb/g stool.

5. Expected values/Reference range:
Negative < 0.03 mg/hHb/g stool

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.