MODIFICATION TO MYALLERGY TEST

K061979 · Immunetech Corporation · JKA · Sep 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061979
• Device Name: MODIFICATION TO MYALLERGY TEST
• Applicant: Immunetech Corporation
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The MyAllergyTest ® is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The The MyAllergyTest ® is intended for use with the MyAllergyTest ® system (K020387). The MyAllergyTest ® is intended for home use by the lay consumer.

Device Story

MyAllergyTest is a sample collection kit; enables lay consumers to collect capillary blood at home; samples mailed to clinical laboratory for allergen-specific IgE profile testing; system used in conjunction with MyAllergyTest system (K020387); modification extends sample stability window from 10 to 30 days; device facilitates remote diagnostic testing; no changes to kit components.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing confirming sample stability for the extended 30-day period.

Technological Characteristics

Sample collection kit; physical components unchanged from predicate. Modification is limited to labeling/limitations regarding sample stability duration (30 days).

Indications for Use

Indicated for the collection of whole blood samples for laboratory testing. No specific patient population, age, or disease state contraindications provided.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• MyAllergyTest system (K020387)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k061979

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:

1. The name and 510(k) number of the submitter's previously cleared device.
ImmuneTech Corporation MyAllergy Test® BLOOD Sample Collection Kit (k021698)

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.

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 to revise the limitations statement to allow testing of the whole blood sample for up to 30 days following collection.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample stability. No changes were made to the kit components.

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 – Risk analysis for product failures (Attachment D). 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 (see Attachment C).

b) A declaration of conformity with design controls (page 5). 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.

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.