INSURE II

K060930 · Enterix, Inc. · KHE · May 4, 2006 · Hematology

Device Facts

• Record ID: K060930
• Device Name: INSURE II
• Applicant: Enterix, Inc.
• Product Code: KHE · Hematology
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

Qualitative detection of human hemoglobin from blood in fecal samples

Device Story

Insure II is an immunochemical fecal occult blood test used for qualitative detection of human hemoglobin in fecal samples. Modification from Insure I involves changing dried conjugate reagent to liquid form. Operation requires adding liquid conjugate and buffer to ports on test card; compared to Insure I which only required buffer. Device used in clinical settings to assist in identifying occult blood; results aid healthcare providers in screening for gastrointestinal conditions. Fundamental scientific technology remains immunochemical test.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and performance testing.

Technological Characteristics

Immunochemical test for human hemoglobin. Modification: liquid conjugate reagent replaces dried conjugate. Test procedure involves adding liquid conjugate and buffer to ports on test card. Fundamental technology remains unchanged.

Indications for Use

Indicated for the qualitative detection of human hemoglobin from blood 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

• Insure I

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER K 060930 Insure
II Immunochemical Fecal Occult Blood Test

This 510(k) submission contains information/data on modifications made to the
SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following
items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a
preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as
described in its labeling HAS NOT CHANGED along with the proposed labeling which
includes instructions for use, package labeling, and, if available, advertisements or
promotional materials (labeling changes are permitted as long as they do not affect the
intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams,
engineering drawings, photographs, user's and/or service manuals in sufficient detail to
demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified
device has not changed.

This change was for modification of the dried conjugate reagent to a liquid form

4. Comparison Information (similarities and differences) to applicant's legally marketed
predicate device including, labeling, intended use, physical characteristics, and test
procedure.

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Same | Qualitative detection of human hemoglobin from blood in fecal samples |
| Technology | Same | Immunochemical test |
| Specimen | Same | Feces |
| Differences | | |
| Item | Device | Predicate |
| Conjugate Solution | Liquid reagent | Dried on test strips |
| Name of device | Insure II | Insure I |
| Test Procedure | Add conjugate and buffer to ports on test card | Add buffer to ports on test card |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification
on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation
activities required, including methods or tests used and acceptance criteria to be
applied

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c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

## 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

| (Reviewer's Signature) | (Date) |
| --- | --- |
| Comments | |

revised:8/1/03