IND ONE STEP OCCULT BLOOD (FOB) TEST

K113506 · Ind Diagnostics, Inc. · KHE · Dec 19, 2012 · Hematology

Device Facts

• Record ID: K113506
• Device Name: IND ONE STEP OCCULT BLOOD (FOB) TEST
• Applicant: Ind Diagnostics, Inc.
• Product Code: KHE · Hematology
• Decision Date: Dec 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Indications for Use

The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

Device Story

The IND One Step Fecal Occult Blood (FOB) Test is a lateral flow, direct binding immunoassay designed for the rapid, qualitative detection of human hemoglobin in fecal samples. Used in clinical laboratories or physician offices by professional staff, the device provides a visual qualitative result. The presence of occult blood serves as an indicator for potential gastrointestinal disorders, aiding clinicians in the diagnostic process for gastrointestinal bleeding. The test is intended for professional use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's technological characteristics and intended use as a qualitative immunoassay for fecal occult blood.

Technological Characteristics

Lateral flow, direct binding immunoassay; qualitative visual readout; professional in vitro diagnostic use; manual test format.

Indications for Use

Indicated for use in clinical laboratories or physician offices for the qualitative detection of human occult blood in stool specimens to assist in diagnosing gastrointestinal disorders.

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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SPECIAL 510(k): Device Modification

Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K113506

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. IND One Step Fecal Occult Blood (FOB) Test, K100031, cleared device
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

- Change of device expiration dating from 12 months to 18 months
- Change of specimen stability from 7 days at 39°F to 28 days at 39 - 86°F (4 - 30 °C)

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample requirements: The sponsor provided data from an accelerated stability study which supports the change of device expiration dating from 12 to 18 months. The sponsor also provided data from studies to support the change in specimen stability from 7 to 28 days at 39 - 86°F (4 - 30 °C).

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
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 (or their preamendment) device.