# 2026-12443: FDA Places Bacillus Protein Test Into Class II 2026-12443, Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-22, effective 2026-06-22; PRIA reads it as touching household money (as of 2026-06-29). - Canonical: https://policyrisk.com/federal-register/2026-12443 - As of: 2026-06-29 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-12443 - Title: Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples - Type: Rule - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 36976 - Published: 2026-06-22 - Effective: 2026-06-22 - Comments close: not stated - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-06-29 ## In one line FDA Places Bacillus Protein Test Into Class II ## Summary The FDA is officially putting a simple test that spots proteins from Bacillus bacteria in human samples into a safer, easier-to-manage category called Class II. This change helps make sure the test is safe and works well while speeding up patient access to cool new medical tools. The new rules kicked in on June 22, 2026, but have been in effect since February 3, 2023, making life simpler for device makers and patients alike. ## Abstract The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. ## Effects PRIA read - Class II Reclassification Speeds Access: benefit, medium. The FDA classified the simple in vitro diagnostic test for detecting secreted proteins from Bacillus species into Class II (special controls). The agency says this Class II classification provides reasonable assurance of safety and effectiveness and will enhance patient access and reduce regulatory… - Premarket 510(k) Requirement Remains: cost, medium. FDA stated that simple IVDs for detection of secreted proteins from Bacillus spp. are subject to premarket notification under section 510(k) and have not been exempted under section 510(m). Manufacturers must submit a 510(k) to market these Class II devices. - Prescription-Only and Lab Distribution Limits: mixed, low. FDA says these simple Bacillus-protein IVDs are prescription in vitro diagnostic devices and limits their distribution to laboratories that follow public health biosafety guidelines. The labeling must include statements that testing is for presumptive identification and that results require confirm… - Detailed Labeling Requirements Imposed: benefit, low. The final order lists extensive labeling requirements that manufacturers must include (e.g., intended use details, sample types, population, warnings that results are presumptive, instructions to minimize exposure and contamination, and reporting instructions). These labeling requirements are codif… - Design Verification and Clinical Study Rules: cost, high. FDA requires manufacturers to provide detailed design description and documentation of analytical studies (e.g., limit of detection, inclusivity, cross-reactivity) and clinical studies or equivalent data sets comparing performance to an FDA-appropriate reference method (see 21 CFR 866.3046(b)(4)). ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2026-12443 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/22/2026-12443/medical-devices-immunology-and-microbiology-devices-classification-of-the-simple-in-vitro-diagnostic) - [2026-12443 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12443.pdf) ## Related - [Previous: 2026-12432, Safety Zone; Offshore, Ritidian Point, GU](https://policyrisk.com/federal-register/2026-12432) - [Next: 2026-12444, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endosc…](https://policyrisk.com/federal-register/2026-12444) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-12443 (as of 2026-06-29).