K Number
K013178
Device Name
DC-UIBC-CO2-CAL, MODEL SE-153
Date Cleared
2001-12-18

(85 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. 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.
Device Description
DC-UIBC-CO, Calibrator is a human based, tyophilized serum which contains nonreactive stabilizers and additives.
More Information

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.

2

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