(44 days)
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Direct Bilirubin Reagent Kit
This document is a 510(k) clearance letter for the Synermed® IR750 Direct Bilirubin Reagent. It is not a study report or a detailed description of the device's performance characteristics. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not present in the provided text.
Based on the provided text, I can extract the following limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain a table of acceptance criteria or reported device performance for the Synermed® IR750 Direct Bilirubin Reagent. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is expected to be comparable, but no specific performance metrics or acceptance criteria are detailed here.
Regarding the other points, the document provides insufficient information to answer most of them:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document gives no details about any specific test set used, its size, or its provenance.
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):
- Not applicable/Not available. This is a reagent for quantitative determination, not an imaging device requiring expert interpretation for ground truth. No information on experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. This is a reagent for quantitative determination. Adjudication methods are typically relevant for interpretive tasks (e.g., radiology reads), not for the performance validation of a chemical reagent.
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 document describes a chemical reagent, not an AI-assisted diagnostic tool or an imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent. Its performance would be evaluated as a standalone assay, not an algorithm. The document doesn't provide details of such an evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. Given this is a quantitative determination of a biomarker, "ground truth" would typically refer to a reference method or a highly accurate "gold standard" measurement of direct bilirubin. However, the document does not specify the method used to establish this.
8. The sample size for the training set:
- Not applicable/Not available. This is a chemical reagent. Training sets are typically associated with machine learning algorithms. While method development involves optimization, it's not referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable/Not available. (See point 8).
Summary of available information from the document:
- Device Name: Synermed® IR750 Direct Bilirubin Reagent
- Intended Use: Quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
- Regulatory Status: Cleared under 510(k) as substantially equivalent to legally marketed predicate devices.
- Regulatory Class: II
- Product Code: CIG
To obtain the detailed information requested, one would need to review the actual 510(k) submission document (if publicly available) or the internal validation studies performed by Synermed Inc. This FDA clearance letter primarily confirms the substantial equivalence determination.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping, curved shapes that resemble a bird in flight or a flowing ribbon.
NOV 4 1998
Ms. Marcia J. Arentz Vice President - Operations Synermed® Inc. 1688 50th Avenue Montreal (Lachine) Quebec, Canada H8T 2V5
Re: K983304 Trade Name: IR750 Direct Bilirubin Reagent Requlatory Class: II Product Code: CIG Dated: September 18, 1998 Received: September 21, 1998
Dear Ms. Arentz:
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 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 requlation (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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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This letter will allow you to beqin 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 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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandinq 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):
Device Name: Direct Bilirubin Reagent Kit
Indications For Use:
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Bilirubin is a product of the catabolism of hemoglobin. Bilirubin is transported through the blood (bound to albumin) to the liver where it is conjugated with glucuronic acid to form the diglucuronide. The bilirubin, in its water soluble conjugated glucuronide form, enters the biliary system for excretion in the bile. Healthy subjects have virtually no detectable conjugated bilirubin. Elevated levels of serum conjugated bilirubin are observed in a variety of conditions including hepatocellular disease, biliary tract obstruction, and some conditions involved in bilirubin metabolism.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
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| --------------------------------------- | -------------- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
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(Division Sign-Off) Division of Clinical
| 510(k) Number | K983304 |
|---|---|
| --------------- | --------- |
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.