(85 days)
DC-UIBC-CAL, Cat. No. SE-090
Not Found
No
The document describes a calibrator for clinical chemistry assays, which is a physical substance used for calibration, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an "in vitro diagnostic calibrator" used to determine values in clinical chemistry assays, not for direct therapeutic treatment of a patient.
No
This device is a calibrator, used to check the linearity and provide a point of reference for clinical chemistry assays, not to diagnose a condition itself.
No
The device description explicitly states it is a "human based, lyophilized serum," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states "For in vitro diagnostic use".
- Purpose: The device is intended to be used as a calibrator in clinical chemistry assays for UIBC and CO2. Calibrators are essential components in IVD tests to ensure accurate measurement of analytes in patient samples.
- "IN VITRO diagnostic use" repeated: The phrase is repeated at the end of the "Intended Use / Indications for Use" section for emphasis.
The description of the device as a "human based, lyophilized serum" further supports its use in a laboratory setting for testing biological samples, which is characteristic of IVD devices.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JIS, JIX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DC-UIBC-CAL, Cat. No. SE-090
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 1 82001
Diagnostics Chemicals Limited
DC-UIBC-CO2-Cal Cat. No. SE-153
Image /page/0/Picture/4 description: The image shows a black and white graphic of what appears to be two letters. The letters are stylized and connected, with the left letter resembling a 'd' and the right letter resembling a 'j'. The letters are bold and have a rounded appearance. The background is white, which makes the black letters stand out.
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 Park |
16 McCarville Street | |
Charlottetown | |
P.E.I., C1A 2E6 | |
Canada | |
(902) 566-1396 | |
Contact: | Nancy Olscamp |
D e: | Trade Name: DC-UIBC-CO₂-Calibrator |
Common Name: DC-UIBC-CO₂-CAL | |
Classification: | Division of Clinical Laboratory Devices |
Panel- Clinical Chemistry | |
Classification 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.
1
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
3
510/K) Notification
Diagnostics Chemicals Limited
DC-UIBC-CO2-Cal Cat. No. __ SE-153
Image /page/3/Picture/3 description: The image contains a stylized graphic of the letters 'ddr' in a bold, sans-serif font. The letters are connected and appear to be a single, unified design element. The overall impression is modern and abstract, with a focus on the interplay of shapes and negative space.
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