(58 days)
Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis, and chronic renal disease.
The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum. When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.
The provided text describes the Wako L-type Fe test, an in vitro diagnostic assay for the quantitative determination of iron in serum. The document states that the safety and effectiveness of this new assay are demonstrated by its substantial equivalency to the Wako Fe B test.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalency | Demonstrated by substantial equivalency to the Wako Fe B test. (No specific thresholds or metrics for equivalency are given beyond this statement.) |
| Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific coefficients of variation or standard deviations are provided.) |
| Minimum Detectable Level | "estimated to be 1.2 mg/dL." |
| Linearity | "determined to be linear to 1000 mg/dL." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the study relies on substantial equivalency to a predicate device and not expert-established ground truth for a test set.
4. Adjudication method for the test set:
- Not applicable as the study relies on substantial equivalency to a predicate device and not independent adjudication.
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:
- Not applicable. This is an in vitro diagnostic device, not an AI-assisted imaging or diagnostic tool relying on human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device described is an in vitro diagnostic assay, meaning it's a lab test. Its performance is inherent to the chemical reaction and measurement process, not an algorithm that operates independently in a standalone fashion like a software device. The "algorithm" in this context is the chemical method itself. The reported performance metrics (precision, linearity, minimum detectable level) are intrinsic to this chemical "algorithm."
7. The type of ground truth used:
- For the Wako L-type Fe test, the "ground truth" for demonstrating its effectiveness is primarily based on comparison to a legally marketed predicate device (Wako Fe B test), and its ability to accurately measure iron concentrations using its described chemical method (bathophenanthroline as a chromogen). The document does not mention external pathology or outcomes data as the ground truth for the device's validation.
8. The sample size for the training set:
- Not applicable. This is an in vitro diagnostic device and does not involve machine learning models requiring training sets.
9. How the ground truth for the training set was established:
- Not applicable. This is an in vitro diagnostic device and does not involve machine learning models requiring training sets.
{0}------------------------------------------------
Image /page/0/Picture/3 description: The image shows the word "Wako" in white text on a black background. The "W" is partially obscured by a white circle on the left side of the image. The text is bold and sans-serif.
JAN 1 5 1999
1984119
Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A
510(k) Summary of Safety and Effectiveness
The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum.
Approximately two thirds of iron in the body is in hemoglobin of red blood corpuscles (RBCs) and the rest is in liver, spleen, bone marrow and other tissues as stored in iron. Numerous cellular enzymes and coenzymes require iron, such as peroxidases and cytochromes. Transport of iron from one organ to another is accomplished by serum iton, bound to transferrin. Measurement of serum iron concentration is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies. There are several methods used for the measurement of iron concentration. The Wako L-type Fe is a method utilizing bathophenanthroline as a chromogen.
When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.
The safety and effectiveness of the Wako L-type Fe assay is demonstrated by its substantial equivalency to the Wako Fe B test.
Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1.2 mg/dL. The Wako L-type Fe assay had determined to be linear to 1000 mg/dL.
Luca Mallus
Tonya Mallory, Senior Manager, Diagnostics January 12, 1999 Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
References:
- Burtis, C.A. and Ashwood, E.R .: Tietz Textbook of Clinical Chemistry, 200 ed., 1. Saunders, Philadelphia, 1994.
{1}------------------------------------------------
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes extending upwards. The bird is positioned within a circular frame that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.
JAN 1 5 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tonya Mallory Senior Manager, Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
K984119 Re: Trade Name: Wako L-type Fe and Wako Fe Calibrator Regulatory Class: I Product Code: CFM 112 II Dated: November 16, 1998 Received: November 18, 1998
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 legally marketed predicate 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 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 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.
{2}------------------------------------------------
Page 2
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
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}------------------------------------------------
Page 1 of 1
510(k) NUMBER (IF KNOWN): _K 984119 L-type E, prakok Calibrator DEVICE NAME: INDICATIONS FOR USE
I von measurements an used in the diagnosis and t of diseases such as in on deficiency an hemochromatosis, and chronic renal disease.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 98419
(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)
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal 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 the limitations in § 862.9.