(11 days)
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No
The summary describes a homogeneous enzyme immunoassay for quantitative analysis of valproic acid. The modifications are related to reagent packaging and compatibility with specific analyzers. There is no mention of AI or ML technology.
No.
This device is an immunoassay kit used for quantitative analysis of valproic acid levels in human serum or plasma, which aids in diagnosis and monitoring therapy, but it does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section states: "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." The explicit mention of "diagnosis" indicates its diagnostic purpose.
No
The device description explicitly states it is a homogeneous enzyme immunoassay with reagents packaged in bottles, indicating a physical, chemical-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative analysis of valproic acid in human serum or plasma." This is a classic example of an in vitro test performed on biological samples outside of the body.
- Purpose: The measurements are used in the "diagnosis and treatment of valproic acid overdose or in monitoring levels of valproic acid to ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Method: It is described as a "homogeneous enzyme immunoassay," which is a common laboratory technique used for in vitro analysis.
N/A
Intended Use / 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. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LEG
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.
1
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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Page 2
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
3
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)