(18 days)
Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.
Dade® TRU-Liquid™ Bilirubin Control Levels 1,2 and 3. Liquid Tri-Level Bilirubin Control. Quality Control Material (Assayed and Unassayed).
This is a 510(k) summary for a quality control material, not a medical device in the typical sense that would have performance criteria related to patient diagnosis or treatment. The acceptance criteria and "study" described are focused on demonstrating substantial equivalence to a predicate device, which is a different type of evaluation than assessing clinical performance.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a diagnostic or therapeutic device. Instead, the "acceptance criterion" for a 510(k) submission for a quality control material is substantial equivalence to an already legally marketed predicate device.
The document states:
"The proposed Dade® TRU-Liquid™ Bilirubin Control is substantially equivalent to the ChemTrak Liquid Bilirubin Control manufactured by Medical Analysis Systems, previously cleared under Document Control No., K833097, on 1/11/84."
Acceptance Criteria for Substantial Equivalence (Inferred):
The acceptance criteria for a quality control material like this would typically involve demonstrating that its characteristics (e.g., stability, commutability, assigned values, matrix effects) are comparable to the predicate device and that it performs its intended function (monitoring accuracy and precision of bilirubin assays) without raising new questions of safety or effectiveness. Specific numerical criteria are not provided in this summary.
Reported Device Performance:
The document does not provide numerical performance data for the Dade® TRU-Liquid™ Bilirubin Control itself. The "performance" assessment is implied through the claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the provided 510(k) summary. For a quality control material demonstrating substantial equivalence, the "test set" would refer to the data collected to compare its characteristics with the predicate. This might involve running both controls on various bilirubin assay systems multiple times. However, the details of such a comparison study (sample size, data provenance) are not included in this high-level summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a quality control material in the same way it would be for an imaging or diagnostic device. "Ground truth" for a quality control material primarily relates to its assigned values, stability, and matrix characteristics, which are determined through laboratory testing and analytical methods, not typically by expert consensus of human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there are no human readers or subjective interpretations involved in establishing the "ground truth" for a quality control material.
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
This is not applicable. The device is a quality control material for laboratory tests, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" for its characteristics (e.g., assigned values for bilirubin, stability) would be established through analytical testing and reference methods in a laboratory setting. This involves precise measurements, calibration against primary standards (if available), and thorough characterization of the material itself. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. Quality control materials do not typically have "training sets" in the context of machine learning or AI. Their characteristics are determined through analytical validation.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
In summary:
The provided document is a 510(k) summary for a quality control material (Dade® TRU-Liquid™ Bilirubin Control). The primary "study" involved in its clearance is demonstrating substantial equivalence to a predicate device (ChemTrak Liquid Bilirubin Control). The information requested regarding AI performance, human reader studies, and training/test sets is not relevant to this type of device or its regulatory clearance process as described in this document.
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-7 1997 JUL
510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Bilirubin Control June 17, 1997
Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Radha Goolabsingh at 305-392-5621 or Marilyn Waxberg at 305-392-5614, or by facsimile at 305-392-5622.
| Trade or Proprietary Name: | Dade® TRU-Liquid™ Bilirubin ControlLevels 1,2 and 3. | |
|---|---|---|
| Common or Usual Name: | Liquid Tri-Level Bilirubin Control | |
| Classification Name: | Quality Control Material (Assayed and Unassayed) | |
| Registration Number: | Manufacturer | |
| Dade International Inc.2173 N.W. 99th AvenueMiami, FL 33172 | 1025506 | |
| Dade International Inc.1851 Delaware ParkwayMiami, Florida 33125 | 1017272 |
The proposed Dade® TRU-Liquid™ Bilirubin Control is substantially equivalent to the ChemTrak Liquid Bilirubin Control manufactured by Medical Analysis Systems, previously cleared under Document Control No., K833097, on 1/11/84. The proposed and the predicate device are intended for use as assayed quality control materials to monitor accuracy and precision in the clinical assay of bilirubin
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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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple, using only black and white, and is designed to be easily recognizable.
JUL - 7 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Marilyn S. Waxburg Director Regulatory Affairs . . . . . . . Dade International, Inc. 2173 N.W. 99th Avenue Miami, FL 33172
Re : K972287 Dade® TRU-Liquid™ Bilirubin Control Requlatory Class: I Product Code: JJX Dated: June 17, 1997 Received: June 19, 1997
Dear Ms. Waxburg:
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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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 (chill of) child at the expire 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 acborizoof 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 requlation (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 compriation 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/dsmamain.html".
Sincerely yours,
Steven Litman
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): j
Device Name: Dade TRU-Liquid Bilirubin Control
Indications For Use:
Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off) of Clinical Laboratory Devices • ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
§ 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.