(25 days)
The Wako NEFA Linearity set is to be used with the Wako NEFAC test kit for the estimation of the linearity limits of the reagent/instrument system for the NEFA analyte.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Wako NEFA Linearity Set," indicating it is substantially equivalent to a predicate device.
Specifically, the document mentions:
- Device Name: Wako NEFA Linearity Set
- Indications For Use: "The Wako NEFA Linearity set is to be used with the Wako NEFA C test kit for the estimation of the linearity limits of the reagent/instrument system for the NEFA analyte."
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes, data provenance, or study design.
- Information about experts, ground truth establishment, or adjudication methods.
- Reference to multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- Details on training set size or how its ground truth was established.
This document is a regulatory approval letter, not a technical study report. To get the information you are requesting, you would need to consult a separate study report or technical documentation for the Wako NEFA Linearity Set.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP | 2 1997
Tonya Mallory . Manager Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
K973072 Re : Wako NEFA Linearity Set Regulatory Class: I Product Code: JJX Dated: August 11, 1997 Received: August 18, 1997
Dear Ms. Mallory:
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 Requlations, Title 21, Parts 800 to 895. ਰ 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 regulation (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 Reqister. 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 Other qeneral 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices
Office of Device Evaluation II your device is classitied (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 Requlations, Title 21, Parts 800 to 895. A 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 regulation (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 In addition, FDA may publish further announcements action. 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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CHEMICALS USA TEL:804-271-7697
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Page _ of _
1973072 510(k) Number (if known):_ inearity wako Device Name:
Indications For Use:
The Wako NEFA Lineari
linearity set is to be used with
the wako NEFAC fest kit for the estimation of the
linearity limits of the reagent/instrument system
for the NEFA analyte.
| Post-It Fax Note | 7671 | Date 8/22/97 | # of pages 1 |
|---|---|---|---|
| To Damia Jackson | From Tonya Mallory | ||
| Co./Dept. FDA/ODE | Co. Wako Diagnostics | ||
| Phone # | Phone # 804 271 7677 | ||
| Fax # 301-594-5941 | Fax # 804 271-7791 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF SEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 6913072
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.