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To: Steakhouse who wrote (11610)3/2/2021 10:37:44 AM
From: tturner1 Recommendation

Recommended By
Steakhouse

  Respond to of 22641
 
steak, remember the change on the presentation. the mile-stone star changed... think it indicated the irritation study was done (star directly across from that line) The cyto study had yet to be done (no star across) From the discription, don't think the latest NR was THAT study. it was different.

ISO 10993-5: Tests for in vitro Cytotoxicity

This cytotoxicity test is performed according to the requirements described in Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ANSI/AAMI/ISO 10993-5). The test is designed to determine the biological response of mammalian cells exposed in vitro to extracts of the devices.

The test article, positive and negative controls are extracted according to the method ISO 10993-12. The original extract is serially diluted and 5 concentrations are used for testing. L-929 cells are treated with extracts of the sample, reagent control, negative control or positive control. Triplicate plates are prepared for each treatment. The cells are incubated for 24 hours and observed microscopically for cytotoxic effects. Cultures are observed under microscopy and graded for reactivity using a 0 to 4 scale. Test article meets the requirement of the test when results are less than a grade of 2.

A report will be issued 4-6 weeks after the receipt of the test substance.



To: Steakhouse who wrote (11610)3/2/2021 10:40:39 AM
From: George692 Recommendations

Recommended By
Canseco
Steakhouse

  Read Replies (1) | Respond to of 22641
 
Correct and this was explained in various releases. However we do not know once the testing is complete if we must go through the 40 day wait or can HC expedite approval as it is basically an amendment. Or perhaps it can be moved quickly due to importance.
Choo Choo