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:

1. Candida albicans and/or Candida tropicalis
1. 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.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the T2Candida 1.1 Panel, aimed at amending labeling to include pediatric patients. The information focuses on analytical and clinical performance to demonstrate substantial equivalence to a previously cleared device.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence by relying on previously obtained performance data and additional tests for pediatric populations and cross-reactivity. Explicit acceptance criteria for clinical performance are not directly stated in percentages (e.g., minimum sensitivity/specificity), but the summary indicates "acceptable performance" was demonstrated. The analytical acceptance criteria for cross-reactivity are defined for the new tests.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Clinical Performance (Pediatric)	Acceptable performance for detecting Candida albicans, Candida parapsilosis, Candida glabrata, and Candida krusei infection in pediatric patients. (Implied: performance comparable to adult studies and sufficient for clinical utility).	Sensitivity (PPA): Ranged from 50-100% in pediatric studies. Specificity (NPA): Ranged from 97-99% in pediatric studies. (Note: These ranges are from external peer-reviewed publications used to support the submission, and low prevalence of positive blood cultures (1.2%) was observed in these studies, which can impact PPA/NPA interpretations).
Analytical Cross-Reactivity	Cross-reactivity defined as an increase in T2 signal above the established cutoff for the Candida detection channel when tested at clinically relevant concentrations, requiring both amplification with Candida primers and detection with capture probes. (Acceptance: No cross-reactivity at clinically relevant concentrations).	Of 5 organisms tested at 10^6 CFU/mL, 2 (S. agalactiae, H. influenzae) showed some cross-reactivity initially. Retesting at "clinically relevant concentrations" (100-1000 CFU/mL): S. agalactiae: No cross-reactivity observed at 1000 CFU/mL, 100 CFU/mL, or 33 CFU/mL. H. influenzae: No cross-reactivity observed at 1000 CFU/mL or 100 CFU/mL. (One instance of 1/3 positive at 100 CFU/mL was observed but not deemed cross-reactive after additional replicates). N. meningitidis, S. mitis, L. monocytogenes: No cross-reactivity at 10^6 CFU/mL.
Internal Control	Internal Control (IC) must be valid for the test to be considered acceptable. (Implicit: Pass rate for IC under various conditions).	Valid for all cross-reactivity tests (3/3 or 6/6 depending on replicates).

2. Sample sizes used for the test set and the data provenance:

Clinical Performance (Pediatric):
- Sample Size: A total of 246 pediatric samples were evaluated across two peer-reviewed publications.
- Data Provenance: The data came from existing studies (peer-reviewed publications) where the T2Candida 1.1 Panel was utilized. The document does not specify the country of origin, but generally, such studies supporting FDA submissions would often include data from the US or other regions with comparable clinical practices. The studies were retrospective in the sense that they were "existing studies" identified and utilized for this submission, although the original data collection within those studies might have been prospective.
Analytical Cross-Reactivity:
- Sample Size:
  - Initial testing: 3 replicates per organism at 10^6 CFU/mL.
  - For organisms showing initial cross-reactivity: Additional 6 replicates (from two additional sample preparations) at 10^6 CFU/mL, and 3 replicates at lower concentrations (1000 CFU/mL, 100 CFU/mL, 33 CFU/mL).
- Data Provenance: This appears to be prospective laboratory testing conducted specifically for this submission, as it's described as "Additional cross-reactivity testing was performed in this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Clinical Performance (Pediatric): The ground truth for this segment of the study was primarily established by blood culture results. The document does not mention the use of experts (e.g., radiologists) for establishing this ground truth, as it's a molecular diagnostic device measuring specific microbial presence. Blood culture is a laboratory-based gold standard for candidemia diagnosis.
Analytical Cross-Reactivity: Ground truth for this was based on known spiked concentrations of the organisms and the inherent characteristics of the T2Candida 1.1 Panel's detection mechanism (T2 signal cutoff). No external human experts are mentioned for ground truth establishment here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Clinical Performance (Pediatric): Not applicable. The ground truth was based on blood cultures.
Analytical Cross-Reactivity: A form of adjudication was applied for cross-reactivity. If an organism demonstrated cross-reactivity at 10^6 CFU/mL, it was "further evaluated with additional replicates from two additional sample preparations." Furthermore, the rule for confirming cross-reactivity was: "Results were not considered cross-reactive if only one replicate demonstrated cross-reactivity." This implies a majority rule or consistency requirement rather than a specific expert consensus adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a molecular diagnostic test for detecting Candida species directly from blood, not an imaging-based AI diagnostic. Therefore, a multi-reader multi-case study involving human readers and AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this is effectively a standalone device. The T2Candida 1.1 Panel (and T2Dx Instrument) runs the assay and provides results (positive/negative for specific Candida groups, or invalid). Its performance is evaluated intrinsically through its ability to detect the target organisms (clinical sensitivity/specificity) and avoid false positives/negatives (analytical cross-reactivity). While a clinician interprets the results, the device's diagnostic output itself (e.g., "Candida albicans/tropicalis detected") is generated by the algorithm/system without human intervention in the diagnostic process of reading the T2MR signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Clinical Performance (Pediatric): Primarily blood culture results.
Analytical Cross-Reactivity: Known concentrations of spiked organisms in blood, with the "ground truth" for cross-reactivity being the absence or presence of specific amplification and detection events as defined by the assay's cutoffs.

8. The sample size for the training set:

The document does not explicitly mention a "training set" in the context of machine learning, as this is a molecular diagnostic device with a defined mechanism (T2MR technology, PCR amplification) rather than a machine learning algorithm that learns from data. Its "training" is inherent in its design and optimization during development, validated by analytical and clinical studies. No specific sample size for "training" is provided in the submission summary.

9. How the ground truth for the training set was established:

As above, "training set" and its associated ground truth establishment methods (e.g., expert labels for images) are not applicable in the typical AI/ML sense for this device. The development process for such molecular diagnostics involves extensive analytical characterization (e.g., limit of detection, inclusivity, exclusivity, precision studies) to define performance parameters and establish expected results, which serves a similar function to providing "ground truth" for the device's operational parameters.

Summary

{0}------------------------------------------------

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)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

Date of Summary	September 13, 2024
Product Name	T2Candida® 1.1 Panel
Sponsor	T2Biosystems, Inc.101 Hartwell AvenueLexington, MA 02421
Correspondent	Rachel GilbertAssociate Director, Regulatory Affairs781-226-2767, 1970rgilbert@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

1. Candida albicans and/or Candida tropicalis
1. 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.

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

{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:1. Candida albicans and/or Candida tropicalis2. Candida parapsilosis3. Candida glabrata and/or Candida kruseiThe 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

{9}------------------------------------------------

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.

Regulation Number and Section

§ 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.