(98 days)
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests.
Since the provided text is a 510(k) clearance letter for the Staphytect Plus/Dryspot Staphytect Plus device, it primarily focuses on the FDA's determination of substantial equivalence to a predicate device. This type of regulatory document does not typically contain detailed information about the acceptance criteria, specific study design, or performance metrics in the way that would be found in a clinical study report or a premarket approval (PMA) application.
Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide what can be inferred or directly stated based on the nature of a 510(k) submission.
Here's an attempt to answer your questions based on the provided text, with clear indications where information is not available:
Device Name: Staphytect Plus / Dryspot Staphytect Plus
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence | Device found to be "substantially equivalent" to predicate devices. | This is the primary regulatory "acceptance criterion" for a 510(k) submission. The letter indicates the device meets this. Specific performance metrics (e.g., sensitivity, specificity, accuracy) that led to this determination are not detailed in this clearance letter. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not available in this document.
- Data Provenance: Not available in this document. A 510(k) submission would typically include a summary of data, but the clearance letter itself doesn't contain these specifics. The manufacturer (Oxoid Limited) is based in England, which might suggest data could originate from there or other regions where the company conducted testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not available in this document.
- Qualifications of Experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not available in this document.
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
- MRMC Study Done: Not applicable. This device is a latex agglutination test for bacterial differentiation, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, human readers or AI assistance in that context are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a laboratory reagent-based test. Its performance is inherent to the chemical/biological reaction, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated in the letter. For a bacterial differentiation test, the ground truth would typically be established by:
- Culture and definitive identification methods: Such as biochemical tests, molecular methods (e.g., PCR), or mass spectrometry (e.g., MALDI-TOF MS) to confirm the presence of Staphylococcus species and the specific factors (clumping factor, Protein A, certain capsular polysaccharides).
- Reference laboratory standards: Comparison to established methods or results from validated reference laboratories.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not available. This is a traditional in vitro diagnostic test, not a machine learning/AI model that typically uses a training set. The development of such a test involves extensive R&D and optimization, but not in the "training set" sense of AI.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As noted above, typical AI/ML training concepts do not apply to this type of device. The development process would establish optimal reagent concentrations and reaction conditions based on known positive and negative controls and clinical isolates, but this is a different paradigm than "training" an algorithm.
Summary of what is known from the document regarding regulatory acceptance:
- Regulatory Class: I
- Product Code: JWX
- FDA Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
- Indication for Use: Latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
- CLIA Complexity: The device may require CLIA complexity categorization (applicant advised to contact CDC).
This document serves as the FDA's clearance notice, confirming that the manufacturer has successfully demonstrated substantial equivalence based on the data submitted in their 510(k) application. It does not provide the detailed scientific and clinical evidence itself.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth QS Manaqer Oxoid Limited Wade Road Basingstoke Hants RG24 8PW ENGLAND
SEP - 8 1997
Re : K972030/S1 Staphytect Plus/Dryspot Staphytect Plus Trade Name: Requlatory Class: I Product Code: JWX Dated: Auqust 22, 1997 Received: August 22, 1997
Dear Mr. Hollingsworth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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) Submission for Oxoid
Staphytect Plus and Dryspot Staphytect Plus
510(K) Number : Unknown
Staphytect Plus Device Name : Dryspot Staphytect Plus
Indications for Use :
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Ade P
510(k) Num
✓ For Prescription Use
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.