DC-UIBC-CO2-CAL, MODEL SE-153

K013178 · Diagnostic Chemicals , Ltd. · JIX · Dec 18, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013178
• Device Name: DC-UIBC-CO2-CAL, MODEL SE-153
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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.

Device Story

DC-UIBC-CO2-Calibrator is a human-serum-based, lyophilized calibrator containing nonreactive stabilizers and additives. It is used in clinical chemistry laboratories to provide a reference point for determining values of unknown patient samples in UIBC and CO2 assays and to verify assay linearity. The product is derived from human blood donors tested for HBsAg, HCV, and HIV. It is intended for professional use by laboratory personnel. The calibrator is reconstituted and processed alongside patient samples on clinical chemistry analyzers; the resulting values are used by clinicians to calibrate assays, ensuring accurate quantification of patient iron binding capacity and carbon dioxide levels, which aids in the diagnosis and management of metabolic and iron-related conditions.

Clinical Evidence

bench testing only

Technological Characteristics

Lyophilized human serum base; contains nonreactive stabilizers and additives; intended for use as a calibrator in clinical chemistry analyzers; no electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC and CO2 to determine values of unknown samples and check linearity over the reportable patient range.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• DC-UIBC-CAL (Cat. No. SE-090)

Submission Summary (Full Text)

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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: _______________________________________________________________________________________________________________________________________________

| <b>Prepared:</b> | September 10, 2001 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|
| <b>Summiteer:</b> | Diagnostic Chemicals Limited |
| <b>Address:</b> | West Royalty Industrial Park<br>16 McCarville Street<br>Charlottetown<br>P.E.I., C1A 2E6<br>Canada<br>[phone] |
| <b>Contact:</b> | Nancy Olscamp |
| <b>D e:</b> | Trade Name: DC-UIBC-CO₂-Calibrator<br>Common Name: DC-UIBC-CO₂-CAL |
| <b>Classification:</b> | Division of Clinical Laboratory Devices<br>Panel- Clinical Chemistry<br>Classification Code- 75 JIS (Clinical Chemistry) |
| <b>Predicate Devices:</b> | 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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# 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. I realize of Compliance at [phone]. 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 [phone] or [phone] 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