(63 days)
The Wako L-type UIBC test is an in vitro diagnostic assay for the quantitative determination of iron in serum. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies.
The Wako L-type UIBC is a method utilizing bathophenanthroline as a chromogen. When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.
The provided text describes a 510(k) submission for the Wako L-type UIBC test, an in vitro diagnostic assay. The primary study proving the device meets acceptance criteria is a demonstration of its substantial equivalency to the Wako UIBC manual test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalency to Predicate Device | The Wako L-type UIBC assay "is demonstrated by its substantial equivalency to the Wako UIBC manual test." The FDA concurs, stating "We have determined the device is substantially equivalent...to legally marketed predicate devices." |
| Precision (Day-to-day consistency) | "Precision studies indicate acceptable values can be obtained on a day to day basis." |
| Minimum Detectable Level | The minimum detectable level for this method is estimated to be 1.8 mg/dL. |
| Linearity Range | The Wako L-type UIBC assay has been determined to be linear to 600 ug/dL. |
2. Sample size used for the test set and the data provenance
The document mentions "precision studies" and "substantial equivalency" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. The "ground truth" for the test appears to be the performance of the predicate device (Wako UIBC manual test) and various analytical performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth, as it's an in vitro diagnostic assay and not a subjective image interpretation task.
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 MRMC study was performed or is relevant in this context. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an in vitro diagnostic assay, which by nature operates as a "standalone" system in terms of producing a quantitative result from a sample. The device measures "unsaturated transferrin concentration in the sample" and then "determines...by calculating the decrement of iron in the Buffer." This suggests an automated or semi-automated process without a human-in-the-loop performance component beyond sample handling and result interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the Wako L-type UIBC assay is its analytical performance relative to a predicate device (Wako UIBC manual test) and established analytical standards (e.g., linearity, minimum detectable level, precision). The "truth" is based on the chemical measurement of UIBC.
8. The sample size for the training set
The document does not refer to a "training set" as this is not a machine learning or AI-based device in the common sense. It's a chemical diagnostic assay.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the development of any chemical assay would be established through rigorous analytical chemistry principles and reference methods to ensure accurate measurement of the analyte.
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JAN 2 0 1999
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Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A
510(k) Summary of Safety and Effectiveness
The Wako L-type UIBC 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 iron, bound to transferrin. Serum transferrin has considerable reserve iron binding capacity, which is called the serum unsataturated iron binding capacity (UIBC), because normally about one third of the iron binding sites of transferrin are occupied by iron. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are 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 UIBC and TIBC.12 The Wako Letype UIBC is a method utilizing bathophenanthroline as a chromogen.
When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.
The safety and effectiveness of the Wako L-type UIBC assay is demonstrated by its substantial equivalency to the Wako UIBC manual 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 1.8 mg/dL. The Wako L-type UIBC assay has determined to be linear to 600 ug/dL.
Kura Mallin
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, 2nd ed., 1. Saunders, Philadelphia, 1994.
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Public Health Service
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JAN 2 0 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
Re: K984122 Trade Name: Wako L-type UIBC and Wako UIBC Calibrator Regulatory Class: I Product Code: JQF 118 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.
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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 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 yours,
Steven Putman
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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510(k) NUMBER (IF KNOWN): _ K98 4122 L-type UIBC, Wako VIBC Calibrator DEVICE NAME: INDICATIONS FOR USE:
capacity measurements oed in and treatmen
Sean Cooper
Division Sign-Off
ivision Sign-Off ) Number
(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)
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(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.