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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 14-612
Standard
USP-NF  M16015_02_01
<86> Bacterial Endotoxins Test Using Recombinant Reagents
Scope/Abstract
The Bacterial Endotoxins Test (BET) described in this chapter contains additional techniques using nonanimal derived reagents to the Bacterial Endotoxins Test 85;. unless specified in an individual monograph, the tests in this chapter are considered alternative tests and must meet the requirements in General Notices 6.30. This test uses a reagent containing
the recombinant Factor C (rFC) protein or a recombinant cascade reagent (rCR) containing recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme. These reagents are used to detect or quantify endotoxins from Gram-negative bacteria in test samples. The test is performed using reagent(s) based on the gene sequence(s) of the relevant factors of the horseshoe crab (Limulus polyphemus, Tachypleus tridentatus, or Carcinoscorpius rotundicauda).

There are two detection techniques that can be employed in this test: the endpoint fluorescence technique, based on the development of fluorescence after activation of a synthetic peptide-fluorophore complex; or the chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromophore complex. To accurately detect endotoxins, the test is carried out using endotoxin-free materials with laboratory controls in place to prevent inadvertent endotoxin contamination.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
1. ISO 11737-3 First Edition 2023-06 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing.

2. ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

3. USP-NF M98830_02_01 <85> Bacterial Endotoxins Test.

4. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff, issued January 2024.

5. FDA Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, issued June 2012.

6. Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Aprajita Garg
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  240-402-7667
  Aprajita.Garg@fda.hhs.gov
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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