Blood glucose and ketone meters and test strips

Published in the Commonwealth of Australia Gazette, No GN 30, 1 August 2007

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS REGULATIONS

I, Larry Kelly, Acting Director, Office of Devices, Blood and Tissues, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of section 42DF of the Therapeutic Goods Act 1989, give notice that the restricted representation described in paragraph (a) below, has been approved for use in advertisements directed to consumers, for the category of products listed in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that use of the goods described in paragraph (b) below:
   "Test or monitor blood ketone levels for people diagnosed with diabetes"
2. Abbott Diagnostic Care blood glucose and ketone meters and test strips
3. The advertisements for these devices must comply with the general provisions about advertising therapeutic goods in Chapter 5, Division 3 of the Therapeutic Goods Act 1989 including the Therapeutic Goods Advertising Code, and
   The references to restricted representations are consistent with the intended purpose recorded on the Australian Register of Therapeutic Goods; and
   The advertisements for these devices must include a statement advising diabetics with elevated blood ketone levels to seek medical advice.

Dated this 16th day of July 2007

LARRY KELLY
Delegate of the Secretary to the Department of Health and Ageing