(32 days)
FOR IN VITRO DIAGNOSTIC USE. This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
Immunoassay kit for quantitative determination of 25-hydroxyvitamin D
The provided text describes a Special 510(k) submission for a device modification to the DiaSorin 25-Hydroxyvitamin D 125I RIA Kit. The submission focuses on demonstrating substantial equivalence to a predicate device (K953567) while highlighting improved analytical sensitivity and precision of the modified device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it refers to a comparative standard:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equal or surpass the performance characteristics of the predicate device (K953567) | • Verification and validation testing demonstrated that the performance characteristics of the modified device equaled or surpassed those of the predicate device.• The modified device demonstrates improved analytical sensitivity and precision compared to the predicate device. |
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: The document states "the use of patient serum samples," but does not specify the exact number of samples used in clinical testing.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document describes an in vitro diagnostic device, and ground truth for such devices is typically established through reference methods or established assays, not necessarily by human expert consensus in the way it would be for an imaging AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to in vitro diagnostic device performance studies as described here. Adjudication methods are more commonly associated with human interpretation of results, particularly in imaging studies.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted human interpretation, typically in contexts like medical imaging. The DiaSorin device is an in vitro diagnostic kit for quantitative determination of a biomarker, not an AI system designed to assist human readers in interpreting complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be a standalone performance evaluation of the modified in vitro diagnostic kit. The "Verification and validation testing" including "the use of patient serum samples" directly evaluates the performance of the device itself (the immunoassay kit) in determining 25-hydroxyvitamin D levels, independent of human interpretive intervention or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific "ground truth" method used. However, for an immunoassay kit, ground truth is typically established by:
- Reference methods: A highly accurate and precise method considered the "gold standard" for measuring the analyte (e.g., LC-MS/MS for vitamin D metabolites).
- Established predicate device/comparators: Comparing results to a well-characterized and legally marketed assay that serves as the basis for performance evaluation.
While the document mentions comparison to the predicate device, it doesn't detail how the predicate device's accuracy itself was derived.
8. The sample size for the training set
This information is not provided. The concepts of "training set" are primarily relevant to machine learning or AI models. This device is an immunoassay kit, which is a chemical and biological assay, not trained using data in the same way an AI algorithm would be.
9. How the ground truth for the training set was established
Not applicable as this is an immunoassay kit, not an AI model requiring a training set developed with ground truth.
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| NOV-16-98 MON 03:59 PMNOV 16 1998 | AMERICANSTANDARDDIASORIN | FAX NO. +301 497 1126 | P. 03 | ||
|---|---|---|---|---|---|
| Special 510(k); Device Modification (cont.)25-Hydroxyvitamin D 125I RIA Kit | |||||
| 8. 510(k) Summary | November 16, 1998 | ||||
| Submitted By: | Judith J. SmithDiaSorin, Inc.9175 Guilford Rd. Suite 100Columbia, MD 21046 | ||||
| Name Of Device:Trade Name: | 25-Hydroxyvitamin D 125I RIA Kit | ||||
| Common Name: | Vitamin D Test System | ||||
| Classification Name: | Vitamin D Test System | ||||
| Device Classification Class II | |||||
| Predicate Device: | 25-Hydroxyvitamin D 125I RIA Kit, K953567, by DiaSorin, Inc. | ||||
| Device Description:hydroxyvitamin D | Immunoassay kit for quantitative determination of 25- | ||||
| Intended Use: | FOR IN VITRO DIAGNOSTIC USE.This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin Dmetabolites in human serum or plasma to be used in theassessment of vitamin D sufficiency. Assay results should be |
used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population. Technological The modified device has the same technological basis as the Comparison: predicate device.
- The labeling of the modified assay is substantially equivalent to Labeling Comparison: that of the predicate device. Changes in labeling directly reflect the device modification and the resultant improvements in analytical sensitivity and precision.
- Verification and validation testing demonstrated that the Nonclinical Testing: performance characteristics of the modified device equaled or surpassed those of the predicate device.
- Verification and validation testing including the use of patient Clinical Testing: serum samples and demonstrated that the performance characteristics of the modified device equaled or surpassed those of the predicate device.
The modified device is substantially equivalent to the predicate Conclusions from Testing: device and demonstrates improved analytical sensitivity and precision.
'
and the comments of the comments of
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NOV
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Judith J. Smith Corporate Director, Worldwide Regulatory Affairs/Quality Systems Diasorin, Inc. 9175 Guilford Rd., Suite 100 Ouarry Park Place Columbia, MD 21046
Re : K983617 25-Hydroxyvitamin D125I RIA Regulatory Class: II Product Code: LCI October 12, 1998 Dated: Received: October 15, 1998
Dear Ms. Smith:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 requlations.
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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 acberibed in your sixti. Foot 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 requlation (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" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Special 510(k): Device Modification (cont.) 25-Hydroxyvitamin D 1251 RIA Kit
- Indications for Use
98361 510(k) Number:
Device Name: 25-Hydroxyvitamin D 125| RIA Kit
Indications For Use:
FOR IN VITRO DIAGNOSTIC USE.
This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983614
7
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.