K262368 · Centers for Disease Control and Prevention · NHT · Oct 7, 2026 · Microbiology
Device Facts
Record ID
K262368
Device Name
B. anthracis Real-time PCR Assay
Applicant
Centers for Disease Control and Prevention
Product Code
NHT · Microbiology
Decision Date
Oct 7, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3045
Device Class
Class 2
Attributes
PCCP
Indications for Use
The B. anthracis Real-time PCR Assay is an in vitro diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from Bacillus anthracis. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, CSF, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax. Results generated from direct specimen testing are presumptive for the identification of B. anthracis. Results generated from culture isolate testing should be used in conjunction with other conventional methods for identification of Bacillus anthracis isolates as part of the LRN Bacillus anthracis Testing Algorithm. The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidences, in addition to the identification of B. anthracis from cultures or detection directly in clinical specimens. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories. The B. anthracis Real-time PCR Assay is also intended for environmental specimen testing for bio threat detection and response. FDA has not evaluated claims related to use of this assay on environmental specimens.
Device Story
Real-time PCR assay for qualitative detection of B. anthracis DNA; utilizes nucleic acid amplification and fluorescent probe detection. Used in CDC-designated laboratories for clinical and environmental specimen testing. Input: clinical samples or culture isolates. Output: presumptive identification of B. anthracis. Results used alongside clinical history, symptoms, and conventional laboratory methods for anthrax diagnosis. PCCP establishes validation protocols for future modifications including new PCR instruments, automated/manual extraction methods, PCR master mixes, and GMP-manufactured oligonucleotide chemistries.
Clinical Evidence
No new clinical data provided in this submission. The device relies on clinical performance data previously accepted under K140426. The PCCP mandates future clinical evaluation studies for specific modifications, requiring pre-specified positive and negative percent agreement (PPA/NPA) and 95% confidence interval bounds compared to a comparator.
Technological Characteristics
Real-time PCR assay; nucleic acid amplification and fluorescent probe detection. Instrumentation includes Applied Biosystems 7500 Fast Dx and QuantStudio Dx Real-Time PCR instruments. PCCP allows for future addition of IVD-labeled PCR instruments, automated/manual extraction systems, and GMP-manufactured oligonucleotide chemistries.
Indications for Use
Indicated for qualitative detection of B. anthracis plasmid and chromosomal DNA in human respiratory samples, whole blood, serum, plasma, lesion swabs, CSF, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax.
Regulatory Classification
Identification
An in vitro diagnostic device for Bacillus species (spp.) detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist of Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused by B. cereus.
Special Controls
*Classification.* Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices for*Bacillus* spp. Detection; Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.” For availability of the guideline document, see § 866.1(e).(c)
*Restriction on Distribution.* The distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.(d)
*Restriction on Use.* The use of this device is restricted to prescription use and must comply with the following:(1) The device must be in the possession of:
(i)(A) A person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(B) A practitioner, such as a physician, licensed by law to use or order the use of such device; and
(ii) The device must be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(2) The label of the device shall bear the statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician” or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
(3) Any labeling, as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(4) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY
### I Background Information:
A 510(k) Number
K262368
B Applicant
Centers for Disease Control and Prevention
C Proprietary and Established Names
B. anthracis Real-time PCR Assay
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NHT | Class II | 21 CFR 866.3045 - In Vitro Diagnostic Device For Bacillus Spp. Detection | MI - Microbiology |
### II Submission/Device Overview:
A Purpose for Submission:
To establish a Pre-determined Change Control Plan (PCCP) to validate certain future device modifications for the CDC B. anthracis Real-time PCR Assay.
B Measurand:
Target DNA sequences from Bacillus anthracis (B. anthracis)
C Type of Test:
Real-time PCR assay
### III Intended Use/Indications for Use:
A Intended Use(s):
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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See Indications for Use below.
# **B Indication(s) for Use:**
The *B. anthracis* Real-time PCR Assay is an *in vitro* diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from *Bacillus anthracis*. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, CSF, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax.
Results generated from direct specimen testing are presumptive for the identification of *B. anthracis*. Results generated from culture isolate testing should be used in conjunction with other conventional methods for identification of *Bacillus anthracis* isolates as part of the LRN *Bacillus anthracis* Testing Algorithm. The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidences, in addition to the identification of *B. anthracis* from cultures or detection directly in clinical specimens.
Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.
The *B. anthracis* Real-time PCR Assay is also intended for environmental specimen testing for bio threat detection and response. FDA has not evaluated claims related to use of this assay on environmental specimens.
# **C Special Conditions for Use Statement(s):**
Rx - For Prescription Use Only
# **D Special Instrument Requirements:**
Not Applicable.
# **IV Device/System Characteristics:**
# **A Device Description:**
No changes were made to the device description under the PCCP. Refer to the public summary for K192871 for the device description.
# **B Principle of Operation:**
No changes were made to the principle of operation under the PCCP. Refer to the public summary for K192871 for a description of test operation.
# **V Substantial Equivalence Information:**
# **A Predicate Device Name(s):**
*B. anthracis* Real-time PCR Assay
K262368 - Page 2 of 7
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# **B Predicate 510(k) Number(s):**
K192871
# **C Comparison with Predicate(s):**
| Device & Predicate Device(s): | K262368 | K192871 |
| --- | --- | --- |
| Device Trade Name | *B. anthracis* Real-time PCR Assay | *B. anthracis* Real-time PCR Assay |
| **General Device Characteristic Similarities** | | |
| Intended Use/Indications For Use | The *B. anthracis* Real-time PCR Assay is an *in vitro* diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from *Bacillus anthracis*. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, CSF, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax. Results generated from direct specimen testing are presumptive for the identification of *B. anthracis*. Results generated from culture isolate testing should be used in conjunction with other conventional methods for identification of *Bacillus anthracis* isolates as part of the LRN *Bacillus anthracis* Testing Algorithm. The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidences, in addition to the identification of *B. anthracis* from cultures or detection directly in clinical specimens. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. | The *B. anthracis* Real-time PCR Assay is an *in vitro* diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from *Bacillus anthracis*. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, CSF, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax. Results generated from direct specimen testing are presumptive for the identification of *B. anthracis*. Results generated from culture isolate testing should be used in conjunction with other conventional methods for identification of *Bacillus anthracis* isolates as part of the LRN *Bacillus anthracis* Testing Algorithm. The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidences, in addition to the identification of *B. anthracis* from cultures or detection directly in clinical specimens. Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories. The *B. anthracis* Real-time PCR Assay is also intended for environmental specimen testing for bio threat detection and response. FDA has not evaluated claims related to use of this assay on |
K262368 - Page 3 of 7
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| | Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories. The *B. anthracis* Real-time PCR Assay is also intended for environmental specimen testing for bio threat detection and response. FDA has not evaluated claims related to use of this assay on environmental specimens. | environmental specimens. |
| --- | --- | --- |
| Analytes Detected | Same | *Bacillus anthracis* virulence plasmids and chromosomal DNA |
| Sample Types | Same | - Swabs from lesions and vesicular material - Whole Blood (EDTA or sodium citrate) - Serum/Plasma - Respiratory specimens (transtracheal aspirates, bronchial lavage, and sputum) - Cerebrospinal fluid - Pleural Fluid - Bacterial culture isolates |
| Principle of Operation | Same | Nucleic acid amplification and fluorescent probe detection |
| Instrumentation | Same | - Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument - QuantStudio Dx Real-Time PCR Instrument |
The subject device is similar to the predicate (K192871), having the same intended use, and the same technological characteristics, with the exception of implementation of a PCCP for modifications to the FDA-cleared CDC *B. anthracis* Real-time PCR Assay that specifies the validation protocols and acceptance criteria for evaluating the following modifications:
1. Addition of a real-time PCR instrument that is *in vitro* diagnostic (IVD)-labeled and used in accordance with its instructions for use.
2. Addition of PCR master mix that is IVD-labeled and used in accordance with its instructions for use or is research use only (RUO)-labeled and qualified lot-by-lot by the CDC Ancillary Reagent Qualification Program.
3. Addition of:
a) A manual extraction method that is IVD-labeled and used in accordance with its instructions for use or is RUO-labeled and qualified lot-by-lot by the CDC Ancillary Reagent Qualification Program.
K262368 - Page 4 of 7
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b) Nucleic acid extraction reagents that are IVD-labeled and used in accordance with their instructions for use or are RUO-labeled and qualified lot-by-lot by the CDC Ancillary Reagent Qualification Program as part of a cleared manual extraction procedure.
c) An automated extraction instrument that is IVD-labeled and used in accordance with its instructions for use.
4. Addition of oligonucleotide chemistries that are manufactured under good manufacturing practices (GMP).
# VI Standards/Guidance Documents Referenced:
Not applicable.
# VII Validation Studies and Acceptance Criteria to Support PCCP Modifications:
Specific test methods for clinical and analytical validation are specified in the PCCP for modifications to the B. anthracis Real-time PCR assay. The following validation studies will be performed in accordance with the PCCP depending on the device modification:
1. Clinical evaluation designed using established and FDA-accepted approaches, with pre-defined acceptance criteria cleared by FDA during this review, to demonstrate substantial equivalence to the predicate device. Clinical performance studies will be conducted to evaluate the following changes according to the established PCCP: addition of a real-time PCR instrument, addition of an automated extraction instrument, addition of nucleic acid extraction reagents or manual extraction method, addition of PCR master mix, or modification of the quencher on the oligonucleotide probes.
2. Limit of Detection (LoD) determination with representative, well-characterized strains of B. anthracis according to established and FDA-accepted approaches. Pre-defined acceptance criteria were found to be appropriate by FDA during this review to demonstrate substantial equivalence to the predicate device. An LoD study will be conducted, according to the established PCCP, to evaluate the addition of a real-time PCR instrument, addition of an automated extraction instrument, addition of nucleic acid extraction reagents or manual extraction method, addition of PCR master mix, or modification of oligonucleotide chemistries.
3. Reproducibility study that is designed according to established and FDA-accepted approaches. Pre-defined acceptance criteria were found to be appropriate by FDA during this review to demonstrate substantial equivalence to the predicate device. A reproducibility study will be conducted, according to the established PCCP, to evaluate addition of a real-time PCR instrument or addition of an automated extraction instrument.
4. Carry-over contamination study demonstrating agreement with expected results compared to the predicate device. A carry-over study will be conducted, according to the established PCCP, to evaluate addition of a real-time PCR instrument or addition of an automated extraction instrument.
# VIII Performance Characteristics (if/when applicable):
K262368 - Page 5 of 7
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# A Analytical Performance:
# 1. Precision/Reproducibility:
Precision/reproducibility data for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426 and K192871. A reproducibility study will be conducted to evaluate addition of a real-time PCR instrument and addition of an automated extraction instrument, according to the established PCCP. Data demonstrating pre-specified agreement with the expected results will be considered acceptable to support these modifications to the device.
# 2. Linearity:
Not Applicable. This is a qualitative test.
# 3. Analytical Specificity/Interference:
Analytical specificity/interference data for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426 and K192871.
# 4. Assay Reportable Range:
Not Applicable. This is a qualitative test.
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Quality control data for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426 and K192871.
# 6. Detection Limit:
Limit of Detection (LoD) data for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426 and K192871. An LoD study will be conducted to evaluate the addition of a real-time PCR instrument, addition of an automated extraction instrument, addition of nucleic acid extraction reagents or manual extraction method, addition of PCR master mix, or modification of the quencher on the oligonucleotide probes, according to the established PCCP. Data demonstrating LoD equivalency will be considered acceptable to support these modifications to the device.
# 7. Assay Cut-Off:
Assay cut-offs for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426.
# B Comparison Studies:
# 1. Method Comparison with Predicate Device:
Refer to the “Clinical Studies” section.
K262368 - Page 6 of 7
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# 2. Matrix Comparison:
Not applicable.
# C Clinical Studies:
Clinical data for the CDC B. anthracis Real-time PCR Assay were reviewed and accepted previously in K140426. Testing of clinical samples will be conducted to evaluate addition of a real-time PCR instrument, addition of an automated extraction instrument, addition of nucleic acid extraction reagents or manual extraction method, addition of PCR master mix, or modification of the quencher on the probes, according to the established PCCP. Data demonstrating that the performance meets or exceeds pre-specified point estimates for both positive and negative percent agreement (PPA and NPA) and the associated lower bounds of the 95% confidence intervals when compared to comparator will be considered acceptable to support these modifications to the device.
# D Clinical Cut-Off:
Not applicable.
# E Expected Values/Reference Range:
Not applicable.
# IX Proposed Change in Labeling:
If the validation studies are performed according to the specified protocols in the PCCP and the validation data meet the specified acceptance criteria established in the PCCP, the modification and supporting validation study results will be included in updated device labeling. The labeling will clearly describe the added modification(s).
# X Conclusion:
The submitted information in this premarket notification, which includes a PCCP for modifications to the B. anthracis Real-time PCR assay, is complete and supports a substantial equivalence decision.
K262368 - Page 7 of 7
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
