(11 days)
The Emit® 2000 Valproic Acid Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of valproic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of valproic acid overdose or in monitoring levels of valproic acid to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
The provided document, K011947, is a 510(k) summary for the Emit® 2000 Valproic Acid Assay. It describes a modified assay that is primarily a packaging change compared to a predicate device. The core assay performance characteristics are stated to be the same as the predicate device. This is a crucial point, as much of the performance data relies on the equivalence to the predicate.
Given this context, the document does not explicitly state specific numerical acceptance criteria for the modified device's performance, nor does it detail a standalone study generating new performance metrics for this specific modified version. Instead, the submission relies on the assertion that the "assay performance characteristics" are identical to the predicate device. Therefore, the "reported device performance" for the modified device is implicitly assumed to be the same as the predicate.
The document focuses on substantiating that the packaging changes do not alter performance.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific numerical acceptance criteria for the modified device's analytical performance (e.g., accuracy, precision, linearity) are not explicitly stated in this 510(k) summary. The submission argues for substantial equivalence based on the modified device having the "same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, the de facto acceptance criteria are that the modified device's performance is demonstrably unchanged from the predicate device due to the packaging modifications, or that it continues to meet the performance established for the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence to Predicate) |
|---|---|
| Analytical characteristics are unchanged from predicate | Performance characteristics are the same as Emit® 2000 Valproic Acid Assay (predicate device) |
| Intended use is unchanged | Quantitative analysis of Valproic Acid in human serum or plasma for diagnosis/treatment monitoring |
| Compatibility with specified analyzers maintained | Compatible with OLYMPUS® AU400/600™, AU800/1000™, and AU2700™ Series Analyzers |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details for a specific test set with sample sizes for the modified device's performance. The submission is based on the premise that the assay capabilities are identical to the predicate. The "study" here is more of a comparison of device characteristics rather than a new performance study.
- Sample Size for Test Set: Not specified, as no new performance study data is presented for the modified device itself.
- Data Provenance: Not applicable in the context of new performance data for the modified device. The "data" refers to the established equivalence of the components and the assay principles.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in-vitro diagnostic (IVD) assay for measuring a specific analyte concentration. Ground truth for such assays is typically established through a reference method or validated calibrators, not through human expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD assay measuring an analyte, there is no "adjudication method" in the sense of expert review for ambiguous cases. Performance is typically assessed through analytical validation (e.g., linearity, precision, accuracy against reference methods).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for devices involving human interpretation (e.g., medical imaging devices). This is an IVD assay, not requiring human interpretation of complex outputs.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in an implicit sense. The "device" (the reagents) functions as an automated system on an analyzer. The intent of the submission is to demonstrate that the reagents themselves perform identically to the predicate reagents, without human intervention affecting the analytical result. The performance of the predicate device would have been established as a standalone analytical system.
7. The Type of Ground Truth Used
For the predicate device (and by extension, the modified device), the ground truth for Valproic Acid concentration would typically be established by:
- Reference Methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS) or High-Performance Liquid Chromatography (HPLC), which are highly accurate and precise methods for determining drug concentrations.
- Certified Reference Materials/Calibrators: Solutions with known, traceable concentrations of Valproic Acid.
8. The Sample Size for the Training Set
No "training set" in the machine learning sense is described or applicable. This is a chemical assay, not an AI/ML algorithm. The assay's "design" is based on established biochemical principles (enzyme immunoassay).
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the development of such an assay would refer to the validation of its analytical characteristics using reference methods and certified calibrators, as mentioned in point 7.
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JUL - 2 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 Valproic Acid Assay
1. Manufacturer and Contact Information:
| Manufacturer: | Syva Company - Dade Behring Inc.20400 Mariani Ave.Cupertino, CA 95014 |
|---|---|
| --------------- | ----------------------------------------------------------------------- |
Susan L. Collins Contact Information: Regulatory Affairs Syva Company - Dade Behring, Inc. 20400 Mariani Avenue Tel: 408 - 366-3840 Fax: 408 - 366-3725
- Date Summary Prepared: 2. June 20, 2001
Device Trade Name: 3.
Emit® 2000 Valproic Acid Assay
Common Name: 4. Enzyme Immunoassay, Valproic Acid
Device Classification Name: 5.
The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Valproic Acid test system" as Class II, 21 CFR Part 862.3645, 91 LEG.
6. Intended Use:
The Emit® 2000 Valproic Acid Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of Valproic Acid in human serum or plasma. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Device Description: 7.
The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
Substantial Equivalence 8.
The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® 2000 Valproic Acid Assay is substantially equivalent to the predicate Emit® 2000 Valproic Acid Assay.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 2 2001
Ms. Susan L. Collins Regulatory Affairs Syva Company - Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014
510(k) Number: K011947 Re: Trade/Device Name: Emit® 2000 Valproic Acid Assay Regulation Number: 862.3645 Regulatory Class: II Product Code: LEG Dated: June 20, 2001 Received: June 21, 2001
Dear Ms. Collins:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 (1 remarket 1 pp . J . be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periours. 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 register. Frease now 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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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 notification. The I Dri imating of cassion 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 If you desire specific daily of your avec devices), please contact the Office of Compliance at additionally 607.10 for in the claighestions on the promotion and advertising of your device, (301) 594-4508. Additionally, for questions of (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 information on your responsibilities and mober (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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Indications for Use Statement
Device Name: Emit® 2000 Valproic Acid Assay 510(k) Number (if known): Kolliqy7
Indications for Use:
The Emit® 2000 Valproic Acid Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of valproic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of valproic acid overdose or in monitoring levels of valproic acid to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Fred Lacy
ion of Clinical Laboratory Deviees Ko11947 t) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.