(266 days)
No
The description focuses on molecular diagnostic techniques (PCR and T2 Magnetic Resonance) for direct detection of Candida species and does not mention any AI or ML components in the device's operation or data analysis.
No.
The document states that the device is for the "presumptive diagnosis of candidemia," not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia." This indicates its purpose is to aid in diagnosing a medical condition.
No
The device description clearly states it is comprised of a "T2Candida 1.1 Panel" (a molecular diagnostic assay with reagents and a cartridge) and a "T2Dx Instrument" (hardware that performs steps after specimen loading). This involves significant hardware components and physical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "direct detection of Candida species in K₂EDTA human whole blood specimens". This indicates that the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The "Device Description" details a "qualitative molecular diagnostic assay" that performs steps like "lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA". These are all processes performed in vitro (outside the living body) on a biological specimen.
- Purpose: The device is indicated for the "presumptive diagnosis of candidemia". Diagnosis is a key function of IVDs.
- Specimen Type: It uses "K₂EDTA human whole blood specimens", which are biological specimens from a human.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
T2Candida® 1.1 Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assy for the direct detection of Candida species in K₂EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups:
-
- Candida albicans and/or Candida tropicalis
-
- Candida parapsilosis
- Candida glabrata and/or Candida krusei 3.
The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei.
The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
The T2Candida positive and negative External Controls (T2Candida QCheck Positive Kit and the T2Dx QCheck Negative Kit) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.
Product codes (comma separated list FDA assigned to the subject device)
PII, NSU
Device Description
The T2Candida 1.1 Panel and T2Dx Instrument is comprised of the T2Candida 1.1 Panel performed on the T2Dx Instrument. The T2Candida 1.1 Panel is a qualitative molecular diagnostic assay that employs a whole blood compatible PCR amplification followed by T2 magnetic resonance (T2MR) detection. The T2Candida 1.1 Panel is performed on the T2Dx Instrument which executes all steps after specimen loading. A K₂EDTA whole blood specimen is loaded onto the T2Candida 1.1 Sample Inlet, which is then placed on the T2Candida 1.1 Cartridge along with the T2Candida 1.1 Reagent Tray. The Reagent Tray contains the internal control, amplification reagent, enzyme and the probe-coupled superparamagnetic particles for each Candida target. Two milliliters of the blood specimen is transferred to the T2Dx Instrument where lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA takes place. Amplification products are detected by T2MR detection using species-specific probes which are attached to the superparamagnetic particles. The assay identifies Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei. The test does not distinguish between C. albicans and C. tropicalis. The test does not distinguish between C. glabrata and C. krusei
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Labeled for adult and pediatric patients (excluding neonates)
Intended User / Care Setting
For prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data from existing studies were used to support the use of T2Candida 1.1 Panel in testing pediatric patient samples. Two (2) peer-reviewed publications were identified where the T2Candida 1.1 Panel was utilized to test pediatric patients and performance was compared to blood culture results. A total of 246 pediatric samples were evaluated in accordance with the T2Candida 1.1 Panel Instructions for Use over the course of the two studies. Patient ages ranged from 23 weeks to 17 years. Low prevalence (as determined by positive blood culture) was observed (1.2%). For all samples, estimates of sensitivity (PPA) ranged from 50-100% and specificity (NPA) ranged from 97-99%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (PPA) ranged from 50-100% and specificity (NPA) ranged from 97-99%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
(a)
Identification. A nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens is a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (limit of detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carryover, and cross contamination.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.
(6) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(7) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.
(8) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
September 13, 2024
T2Biosystems, Inc. Rachel Gilbert Manager, Regulatory Affairs 101 Hartwell Avenue Lexington, Massachusetts 02421
Re: K234063
Trade/Device Name: T2Candida 1.1 Panel Regulation Number: 21 CFR 866.3960 Regulation Name: Nucleic Acid-Based Device For The Amplification, Detection, And Identification Of Microbial Pathogens Directly From Whole Blood Specimens Regulatory Class: Class II Product Code: PII, NSU Dated: August 15, 2024 Received: August 15, 2024
Dear Rachel Gilbert:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K234063
Device Name T2Candida 1.1 Panel
Indications for Use (Describe)
T2Candida 1.1 Panel and T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in K2EDTA human whole blood specimens with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups:
-
Candida albicans and/or Candida tropicalis
-
Candida parapsilosis
-
Candida glabrata and/or Candida krusei
The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei.
The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood cultures are necessary to recover organisms for susceptibility testing or further identification.
The T2Candida positive and negative External Controls (T2Candida QCheck Postive Kit and the T2Dx QCheck Negative Kit) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
---|---|
---------------------------------------------- | --------------------------------------------- |
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510(k) Summary
Date of Summary | September 13, 2024 |
---|---|
Product Name | T2Candida® 1.1 Panel |
Sponsor | T2Biosystems, Inc. |
101 Hartwell Avenue | |
Lexington, MA 02421 | |
Correspondent | Rachel Gilbert |
Associate Director, Regulatory Affairs | |
781-226-2767, 1970 | |
rgilbert@t2biosystems.com | |
Device Trade or Proprietary Name | T2Candida® 1.1 Panel |
Regulation | 21 CFR 866.3960 |
Common Name | Candida Species Nucleic Acid Detection System |
Product Code | PII, NSU |
Classification | Class II |
The purpose of this pre-market 510(k) submission is to amend the T2Candida 1.1 Panel cleared under K173536 to amend labeling regarding testing in pediatric patients.
No significant changes have been made to the device components or technology since the clearance of the T2Candida 1.1 Panel.
5
Intended Use
T2Candida® 1.1 Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assy for the direct detection of Candida species in K₂EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups:
-
- Candida albicans and/or Candida tropicalis
-
- Candida parapsilosis
- Candida glabrata and/or Candida krusei 3.
The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei.
The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
The T2Candida positive and negative External Controls (T2Candida QCheck Positive Kit and the T2Dx QCheck Negative Kit) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.
Limitations
For prescription use only.
Please refer to the T2Candida 1.1 Panel labeling for a more complete list of warnings, precautions, and contraindications.
Methodology
The T2Candida 1.1 Panel utilizes magnetic resonance-based detection (T2®MR technology) to qualitatively detect five species of Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei, direct from K2EDTA-treated human whole blood. The T2Candida 1.1 Panel, run on the T2Dx instrument, performs sample concentration and Candida target DNA amplification for direct detection of species-specific amplicon at a limit of detection as low as 1 CFU/mL in approximately 3.5 hours. The test incorporates an Internal Control (IC) for monitoring test performance.
Device Description
The T2Candida 1.1 Panel and T2Dx Instrument is comprised of the T2Candida 1.1 Panel performed on the T2Dx Instrument. The T2Candida 1.1 Panel is a qualitative molecular diagnostic assay that employs a whole blood compatible PCR amplification followed by T2 magnetic resonance (T2MR) detection. The T2Candida 1.1 Panel is performed on the T2Dx Instrument which executes all steps after specimen loading. A K₂EDTA whole blood specimen is loaded onto the T2Candida 1.1 Sample Inlet, which is then placed on the T2Candida 1.1 Cartridge along with the T2Candida 1.1 Reagent Tray. The Reagent Tray contains the internal control, amplification reagent, enzyme and the probe-coupled superparamagnetic
6
particles for each Candida target. Two milliliters of the blood specimen is transferred to the T2Dx Instrument where lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA takes place. Amplification products are detected by T2MR detection using species-specific probes which are attached to the superparamagnetic particles. The assay identifies Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei. The test does not distinguish between C. albicans and C. tropicalis. The test does not distinguish between C. glabrata and C. krusei
Analytical Studies
Cross-reactivity was previously assessed in DEN140019. Additional cross-reactivity testing was performed in this submission using five organisms clinically relevant to pediatric populations: Streptococcus agalactiae, Listeria monocytogenes, Haemophilus influenzae, Streptococcus mitis, and Neisseria meningitidis.
lsolates were tested in triplicate at a concentration of 10° CFU/mL. Any organism that demonstrated cross-reactivity or gave an invalid result was further evaluated with additional replicates from two additional sample preparations at the same concentration and was tested at lower, more clinically relevant concentrations of organisms in blood (100-1000 CFU/mL).
Cross-reactivity was defined as an increase in the T2 signal above the established cutoff for the Candida detection channel when tested at clinically relevant concentrations. Cross-reactivity required both amplification of the organism with Candida primers and subsequent detection with any of the capture probes. Of the five organisms tested, two demonstrated cross-reactivity at 10° CFU/mL (S. agalaction, H. influenzae). Cross-reactivity was not observed when the organisms were re-tested at 1000 CFU/mL. The remaining three organisms did not demonstrate cross-reactivity (Table 1).
| Species | Concentration
(CFU/mL) | Positive Results per Detection Panel | | | Internal Control |
|-------------------------|---------------------------|--------------------------------------|-----|-----|------------------|
| N. meningitidis | 106 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| S. mitis | 106 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| L. monocytogenes | 106 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| S. agalactiae | 106 CFU/mL | 0/3 | 0/3 | 1/3 | Valid (3/3) |
| | 106 CFU/mL * | 0/6 | 0/6 | 1/6 | Valid (6/6) |
| | 1000 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| | 100 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| | 33 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| H. influenzae | 106 CFU/mL | 0/3 | 0/3 | 2/3 | Valid (3/3) |
| | 1000 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
| | 100 CFU/mL | 0/3 | 0/3 | 1/3 | Valid (3/3) |
| | 100 CFU/mL * | 0/6 | 0/6 | 0/6 | Valid (6/6) |
| | 33 CFU/mL | 0/3 | 0/3 | 0/3 | Valid (3/3) |
Table 1: T2Candida Cross-Reactivity Results
A/T = C. albicans/ C. tropicalis; P = C. parapsilosis; K/G = C. krusei / C. glabrata
7
*For any cross-reactive result, two additional unique sample preparations were tested at the same concentration. Results were not considered cross-reactive if only one replicate demonstrated crossreactivity.
Summary of Clinical Performance - Pediatric Subjects
Clinical data from existing studies were used to support the use of T2Candida 1.1 Panel in testing pediatric patient samples. Two (2) peer-reviewed publications were identified where the T2Candida 1.1 Panel was utilized to test pediatric patients and performance was compared to blood culture results. A total of 246 pediatric samples were evaluated in accordance with the T2Candida 1.1 Panel Instructions for Use over the course of the two studies. Patient ages ranged from 23 weeks to 17 years. Low prevalence (as determined by positive blood culture) was observed (1.2%). For all samples, estimates of sensitivity (PPA) ranged from 50-100% and specificity (NPA) ranged from 97-99%.
Results of these studies and the existing adult study data demonstrate acceptable performance of the T2Candida 1.1 Panel to detect Candida albicans, Candida parapsilosis, Candida glabrata and Candida krusei infection.
8
Predicate Comparison
Table 2: Comparison Between T2Candida 1.1 Panel and Predicate Device
Characteristic | T2Candida 1.1 Panel (New Device) | T2Candida 1.1 (K173536) (Predicate Device) |
---|---|---|
FDA Product Code | PII, NSU | Same |
Regulatory Classification | Class II | Same |
Regulation Number | 21 CFR 866.3960 | Same |
Intended Use/Indications for Use | T2Candida® 1.1 Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assay for the direct detection of Candida species in K₂EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups: |
-
Candida albicans and/or Candida tropicalis
-
Candida parapsilosis
-
Candida glabrata and/or Candida krusei
The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei.
The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
The T2Candida positive and negative External Controls (T2Candida QCheck Positive Kit and the T2Dx QCheck Negative Kit) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems. | Same |
| Characteristic | T2Candida 1.1 Panel (New Device) | T2Candida 1.1 (K173536) (Predicate Device) |
| Patient Population and Exclusions | Labeled for adult and pediatric patients (excluding neonates) | Labeled for adult patients |
| Sample Type | A minimum of 3 mL whole blood collected in a 4 mL blood collection tube with K₂EDTA anticoagulant. | Same |
| Test Platform | T2Dx Instrument | Same |
| Reagent Trays | T2Candida 1.1 Test Reagents for detection of Candida species | Same |
| Test Cartridge Format | T2Candida 1.1 Test Cartridge and disposables | Same |
| Test Principle | Nucleic acid amplification followed by T2 magnetic resonance detection | Same |
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T2Biosystems, Inc. T2Candida® 1.1 Panel 510(k) Summary
Page 6 of 6
Conclusions
The submitted information in this premarket notification supports a substantial equivalence decision.