(43 days)
The device is intended to be used with Wako vanadate bilirubin methods to establish calibration points for the determination of Total and Direct bilirubin values in human serum specimens.
The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct bilirubin methodology for the determination of total and direct bilirubin in serum.
The provided text describes a Wako Bilirubin Calibrator, an in vitro diagnostic device, and not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study details relevant to AI devices (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or explicitly mentioned in the provided document.
Instead, this document focuses on demonstrating substantial equivalence to an existing predicate device based on performance characteristics relevant to calibrators.
Here's an attempt to extract relevant information per your requested format, acknowledging the limitations for an IVD device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit / Explicit) | Reported Device Performance (Wako Bilirubin Calibrator vs. Predicate) | Meets Criteria? |
|---|---|---|---|
| Substantial Equivalence | High correlation with predicate standard. | Total Bilirubin: Correlation Coefficient = 1.000 | Yes |
| Direct Bilirubin: Correlation Coefficient = 0.9999 | Yes | ||
| Regression Equation (Closeness to Ideal y=x) | Linear relationship with predicate standard. | Total Bilirubin: y = 0.99x - 0.0027 | Yes (very close to y=x) |
| Direct Bilirubin: y = 0.97x - 0.0031 | Yes (very close to y=x) | ||
| Intended Use Compatibility | Designed to be used with Wako's total and direct bilirubin methodology. | Confirmed by statement: "The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct Bilirubin methodology..." | Yes |
Description of the Study Proving Acceptance Criteria:
The study described is a comparison study designed to demonstrate substantial equivalence of the Wako Bilirubin Calibrator to the legally marketed Wako Bilirubin Standard (predicate device).
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated. The document refers to "comparison studies" but does not provide the number of samples or measurements performed.
- Data Provenance: Not explicitly stated. It's an in-house comparison against a predicate device, likely performed by Wako Chemicals USA, Inc. The country of origin for the data is implicitly the USA, where the company and the study would have taken place. It is a prospective study in the sense that Wako conducted it to support their 510(k) submission for this specific calibrator.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A) for this type of device. The "ground truth" here is the performance of the predicate device (Wako Bilirubin Standard), which is already established as a legally marketed product. No human experts were involved in establishing ground truth in the way they would for medical image interpretation.
4. Adjudication method for the test set:
- N/A. As the comparison is against an existing standard, there's no "adjudication" in the sense of resolving discrepancies between human readers or algorithm outputs. The comparison is statistical.
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:
- N/A. This is an in vitro diagnostic calibrator, not an AI/ML device, and therefore no MRMC studies are relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical calibrator used in analytical instrumentation, not an algorithm. Its "standalone" performance is assessed by its characteristics and its ability to calibrate the intended assays accurately.
7. The type of ground truth used:
- The "ground truth" refers to the measurements obtained using the Wako Bilirubin Standard (predicate device) against which the new Wako Bilirubin Calibrator was compared. It's a reference standard rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- N/A. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the date November 9, 1999. The month is abbreviated to NOV. The day is the number 9. The year is 1999.
Image /page/0/Picture/1 description: The image shows the word "Wako" in bold, white letters against a black background. The text is simple and clear, with a modern sans-serif font. The word is positioned in the upper-left corner of the black square.
Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.
/<993219
510(k) Summary of Safety and Effectiveness
The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct The Wako Billitoom Canbrator is Gesigned to overhodology for the determination of total and direct bilirubin in serum.
The safety and effectiveness of the Wako Bilirubin Calibrator is demonstrated by its The Saley and crised of the Wako Bilirubin Standard. Both calibration material are substantial equivalency to me Wallo Dhilinobin in serum. In comparison studies against the predicate bilirubin standard, a correlation coefficient of 1.000 and a regression equation of y =0.99x -.0027 was obtained for total bilirubin and a correlation coefficient of 0.9999 and a regression equation of y=0.97x -0.0031 for direct bilrubin.
Luiza Valluz
September 22, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes suggesting a head, body, and legs. The symbol is rendered in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237
Re: K993219
Trade Name: Wako Bilirubin Calibrator Regulatory Class: II Product Code: JIS Dated: September 22, 1999 Received: September 27, 1999
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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K993219 510(k) umber (if known): wa Ko irubin Device Name: alibrator
Indications For Use:
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(Division Sign-Off)
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510(k) Number: K 993219
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Prescription Use (Per 21 CFR 801.109
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.