SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES by TREK DIAGNOSTIC SYSTEMS, INC.

The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H.influenzae.

This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32pg/mL) for use with the Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for:

Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) device, specifically the Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates, Daptomycin (0.03 - 32 ug/mL). It focuses on the regulatory approval process and includes the "Indications for Use" statement.

While it mentions the device is for "quantitatively and or qualitative susceptibility testing" and "plates can either be read manually or automatically," it does not provide the acceptance criteria (e.g., specific accuracy thresholds) or the detailed study results that demonstrate the device meets those criteria.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be extracted from the provided text.

Here is what can be inferred or stated as not present:

Acceptance Criteria and Device Performance Study Information:

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

Not provided in the document. The document is a 510(k) clearance letter, confirming substantial equivalence to a predicate device, but it does not detail the specific performance criteria (e.g., essential agreement, categorical agreement percentages) that were evaluated or the results achieved in the clinical or laboratory studies.

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

Not provided in the document. The document does not specify the number of isolates or samples used in the "test set" for performance evaluation.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be found in the detailed study report submitted with the 510(k).

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

Not applicable/Not provided in the document. For AST devices, the "ground truth" (or reference method) is typically established by a "gold standard" laboratory method (e.g., broth microdilution or agar dilution as per CLSI guidelines), not by human experts interpreting images or clinical data. The document does not mention human experts for ground truth establishment.

4. Adjudication method for the test set:

Not applicable/Not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation of complex data (e.g., medical images, pathology slides) is involved to establish ground truth. For AST, the reference method provides a direct, measurable result, not requiring adjudication in the same way.

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

Not applicable/Not provided in the document. This type of study is relevant for AI-powered diagnostic aids where human readers interpret results. This device is an in vitro diagnostic (IVD) susceptibility plate; while it can be read manually or automatically, the core function is a direct measurement for antimicrobial susceptibility, not an AI-assisted human diagnostic interpretation. Therefore, an MRMC study in this context is unlikely.

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

Partially applicable/Inferred: The document mentions "plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS." For the automated reading, there would have been a standalone performance evaluation of the instrument/algorithm against the reference method. However, the specific details or results of such a standalone performance are not provided in this clearance letter.

7. The type of ground truth used:

Inferred (Standard for AST devices): For antimicrobial susceptibility testing, the "ground truth" or reference method is typically a CLSI (Clinical and Laboratory Standards Institute) or ISO-standardized reference broth microdilution or agar dilution method. The document does not explicitly state this, but it is the standard practice for validating such devices.

8. The sample size for the training set:

Not applicable/Not provided in the document. This document does not describe a machine learning or AI algorithm in a way that would require a separate "training set" for model development, distinct from a test set for performance evaluation. While "automatic" readers exist, the clearance letter does not provide details on how those readers were developed or the data used.

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

Not applicable/Not provided in the document. (See explanation for point 8).

Summary of what the document does provide:

Device Name: Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates, Daptomycin (0.03 - 32 ug/mL)
Intended Use: In vitro diagnostic products for quantitatively and/or qualitatively susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens.
New Addition: This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32µg/mL) for use with the existing Sensititre® plates.
Reading Methods: Can be read manually or automatically (Sensititre Autoreader and/or ARIS for Streptococcus species, manually for H. influenzae).
Regulatory Status: 510(k) cleared (K062841) for marketing based on substantial equivalence.

To answer your full request, you would typically need access to the full 510(k) submission summary or a detailed clinical/analytical study report, which contains the specific performance data presented to the FDA. This clearance letter is the result of that submission, not the submission itself.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and science. The department's name is inscribed in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems Inc. Magellan Biosciences 982 Keynote Circle, Suite 6 Cleveland, OH 44131

DEC 2 0 2006

Re: K062841

Trade/Device Name: Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates Daptomycin (0.03 - 32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY. LRG Dated: December 14, 2006 Received: December 18, 2006

Dear Ms. Knapp:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, artopm

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO 6 2 84 |

Device Name: Sensititre® Haemophilus influenzae / Streptococcus species MIC Susceptibility plates, Daptomycin (0.03-32ug/mL)

Indications For Use:

Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of

Lueddi W. Poole

Division

ce of In Viro Diagnostic Device

210(K) K062841

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).