(85 days)
For in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity) and CO2(Carbon Dioxide). DC-UIBC-CO2 Calibrator may be used to check the linearity over the reportable patient range of UIBC assays.
Clinical Chemistry assays may require a point of reference to determine the values of unknown samples. DC-UIBC-CO2-CAL may be used for this purpose in UIBC and CO2 assays.
For IN VITRO diagnostic use.
DC-UIBC-CO, Calibrator is a human based, tyophilized serum which contains nonreactive stabilizers and additives.
The provided text describes a 510(k) submission for the DC-UIBC-CO2-Cal calibrator. It appears to be a regulatory submission document for a medical device rather than a study report that details acceptance criteria and performance against those criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.
Based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or provide a table of performance data against such criteria. The submission is for a calibrator, which typically undergoes validation for stability, accuracy, and homogeneity, but these specific metrics and their acceptance thresholds are not detailed here.
2. Sample sized used for the test set and the data provenance:
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a calibrator and not a diagnostic device requiring ground truth established by experts for performance evaluation on patient samples.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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, as this is a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a calibrator, not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of diagnostic performance. For a calibrator, the "truth" would be its assigned target values, established through a rigorous analytical process. The text mentions it's a "human-based, lyophilized serum," implying its composition is designed to mimic human serum for calibration purposes.
8. The sample size for the training set:
Not applicable. Calibrators are not "trained" in the way AI algorithms are.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available from the text:
- Device Type: DC-UIBC-CO2-Calibrator, a human-based, lyophilized serum.
- Intended Use: For in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity) and CO2 (Carbon Dioxide). It may also be used to check linearity over the reportable patient range of UIBC assays.
- Predicate Device: DC-UIBC-CAL, Cat. No. SE-090. This implies that the current device's substantial equivalence was established by comparing it to this already marketed device. The performance of the current device would have been demonstrated to be substantially equivalent to the predicate, but the specific details of that comparison are not in this excerpt.
- Safety Information: The product is prepared from blood donors tested and shown to be free from HBsAg and antibodies to HCV and HIV, but standard precautions for handling laboratory reagents are advised.
- Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
To provide the requested information, a more detailed study report or validation protocol for the DC-UIBC-CO2-Calibrator would be required, which would typically be part of a larger 510(k) submission but is not included in this summary document.
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DEC 1 82001
Diagnostics Chemicals Limited
DC-UIBC-CO2-Cal Cat. No. SE-153
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20.0 510(K) SMDA SUMMARY
510 (k) SUMMARY INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| Prepared: | September 10, 2001 |
|---|---|
| Summiteer: | Diagnostic Chemicals Limited |
| Address: | West Royalty Industrial Park16 McCarville StreetCharlottetownP.E.I., C1A 2E6Canada(902) 566-1396 |
| Contact: | Nancy Olscamp |
| D e: | Trade Name: DC-UIBC-CO₂-CalibratorCommon Name: DC-UIBC-CO₂-CAL |
| Classification: | Division of Clinical Laboratory DevicesPanel- Clinical ChemistryClassification Code- 75 JIS (Clinical Chemistry) |
| Predicate Devices: | DC-UIBC-CAL, Cat. No. SE-090 |
Device Description:
DC-UIBC-CO, Calibrator is a human based, tyophilized serum which contains nonreactive stabilizers and additives.
Exercise the normal precautions required for handling all laboratory reagents. This product has been prepared exclusively from the blood of donors tested individually and shown by FDA-approved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.
Intended Use:
For in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity) and CO2(Carbon Dioxide). DC-UIBC-CO2 Calibrator may be used to check the linearity over the reportable patient range of UIBC assays.
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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 image of an eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
DEC 1 8 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene J. Walker Manager of Research and Development, Clinical Chemistry Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada C1E 2A6
Re: K013178 Trade/Device Name: DC-UIBC-CO2-Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; Dated: November 20, 2001 Received: November 21, 2001
Dear Ms. Walker:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his leation. The FDA finding of substantial equivalence of your device to a legally marketed predication. The ID 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 1 IT you desire specific active to fagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1500. I realize of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monthanon on your respectional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butmein
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) Notification
Diagnostics Chemicals Limited
DC-UIBC-CO2-Cal Cat. No. __ SE-153
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INDICATIONS FOR USE
K013178 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
DC-UIBC-CO,-Calibrator Device Name: ____________
Indications for Use:
Clinical Chemistry assays may require a point of reference to determine the values of unknown samples. DC-UIBC-CO2-CAL may be used for this purpose in UIBC and CO2 assays.
Fo. N VITRO diagnostic use.
Thomas. Crook for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 16.01. 98 14 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
§ 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.