(37 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Meropenem in the dilution range of 0.016 - 2 ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzac isolates. The "Indications for Use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (excluding penicillin-resistant strains)
Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Meropenem
The provided text describes the 510(k) premarket notification for the "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Meropenem." This submission is for the addition of Meropenem to an existing in vitro diagnostic product for clinical susceptibility testing.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal for Meropenem) | Reported Device Performance (Meropenem) |
|---|---|
| No explicit acceptance criteria stated in the provided text. | The document does not provide specific performance metrics (e.g., essential agreement, categorical agreement, reproducibility) for Meropenem. It only states that the device is "substantially equivalent" to legally marketed predicate devices. |
Explanation: The document is a 510(k) clearance letter. In 510(k) submissions for antimicrobial susceptibility testing (AST) devices, the acceptance criteria typically involve demonstrating substantial equivalence to a predicate device, which usually means meeting specific performance targets (e.g., essential agreement and categorical agreement within defined percentages) when comparing the new device's results to a reference method (like broth microdilution or agar dilution). However, these specific numerical criteria and the actual performance results are not detailed in this summary letter. The letter simply confirms the FDA's determination of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number or qualifications of experts used to establish ground truth. For AST devices, the "ground truth" (or reference method) is typically established by well-defined laboratory methodologies, not individual expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. For AST, the reference method results are generally considered definitive, not subject to adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, as this is not applicable for an in vitro diagnostic device like an antimicrobial susceptibility test. MRMC studies are typically used to evaluate the performance of diagnostic imaging devices or other tests that rely on human interpretation.
6. Standalone Performance Study
Yes, a standalone performance study would have been performed as part of the 510(k) submission to demonstrate the performance of the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Meropenem. This study would involve testing a set of bacterial isolates with known susceptibility to Meropenem using the device and comparing the results to a reference method (e.g., broth microdilution). While the results of this study are not in this letter, such a study is fundamental to gaining 510(k) clearance for an AST device.
7. Type of Ground Truth Used
The ground truth for antimicrobial susceptibility testing is typically established by a reference method, most commonly:
- Broth Microdilution (BMD): This is the gold standard for determining minimum inhibitory concentrations (MICs).
- Agar Dilution: Another established reference method.
The FDA's review for AST devices requires comparison to these standard methods.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. For in vitro diagnostic products, particularly those using established methodologies, a distinct "training set" in the machine learning sense is often not applicable in the same way as for AI/ML-driven devices. The development of an AST panel relies on extensive historical data and established breakpoints.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the typical sense of AI/ML training data. The "ground truth" (reference method) for establishing the validity and accuracy of the susceptibility plate would have been based on standardized laboratory protocols (e.g., CLSI guidelines) for determining resistance and susceptibility profiles of various bacterial isolates to Meropenem. These protocols define how to obtain accurate MIC values using reference methods.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
K013925 Re:
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Meropenem Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: November 13, 2001 Received: November 14, 2001
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 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntis lotter will and hype ding 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Jory of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (If known): Kol 3925
Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Indications For Use:
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Meropenem in the dilution range of 0.016 - 2 ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzac isolates. The "Indications for Use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (excluding penicillin-resistant strains)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Dechoes | |
|---|---|
| (Division Sign/Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K013925 |
| Prescription Use(Per 21 CFR 801.109 | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ----------------------------------------- | ----------------------------------------- | ---- | ---------------------- |
§ 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).