AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

K981706 · Abbott Laboratories · JIX · Jul 9, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981706
• Device Name: AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
• Applicant: Abbott Laboratories
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Ammonia Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Ammonia. The Bilirubin Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Bilirubin. The Carbon Dioxide Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Carbon Dioxide. The HDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for HDL. The Iron/Magnesium Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Iron and Magnesium. The LDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for LDL. The MC Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Albumin, Calcium, Cholesterol, Creatinine, Glucose, Phosphorus, Total Protein, Triglyceride, Urea Nitrogen, and Uric Acid. The UPro Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for protein in urine and CSF. The ISE Calibrator Levels 1 and 2 are intended for in vitro diagnostic use in clinical chemistry assays for Sodium, Potassium, and Chloride.

Device Story

Abbott Clinical Chemistry Calibrators serve as reference standards for clinical chemistry assays; used to establish calibration curves on the ALCYON 300/300i analyzer; enables accurate quantitation of analytes including ammonia, bilirubin, CO2, HDL, iron, magnesium, LDL, albumin, calcium, cholesterol, creatinine, glucose, phosphorus, total protein, triglycerides, urea nitrogen, uric acid, urine/CSF protein, sodium, potassium, and chloride; used by laboratory professionals in clinical settings; output consists of calibrated reference values for patient sample analysis; facilitates clinical decision-making by ensuring accuracy of diagnostic test results.

Clinical Evidence

No clinical data. Performance was established via bench testing using the ALCYON 300/300i analyzer to generate calibration curves for the specified analytes, supporting the performance data of the associated reagent 510(k) submissions.

Technological Characteristics

In vitro diagnostic calibrators for clinical chemistry. Used for establishing reference points for analyte measurement. Designed for use with the ALCYON 300/300i analyzer system.

Indications for Use

Indicated for use in clinical chemistry test systems to establish points of reference for the measurement of substances in human specimens.

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.

Reference Devices

• Ammonia (K981467)
• Total Bilirubin (K981336)
• Direct Bilirubin (K981222)
• Carbon Dioxide (K981231)
• Direct HDL (K981224)
• Iron (K981241)
• Magnesium (K981192)
• Direct LDL (K981303)
• Sodium, Potassium, Chloride (K974779)
• Albumin BCG (K981468)
• Albumin BCP (K981457)
• Calcium (K981232)
• Cholesterol (K981476)
• Creatinine (K981240)
• Glucose (K981185)
• Phosphorus (K981118)
• Triglyceride (K981223)
• Urea Nitrogen (K981123)
• Uric Acid (K981189)
• Urine/CSF Protein (K981295)

Submission Summary (Full Text)

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K981706

9 1998 JUL

## 510(k) Summary

| Submitter's Name/Address | Abbott Laboratories |
|--------------------------|------------------------|
| | 1920 Hurd Drive |
| | Irving, Texas 75038 |
| Contact Person | Mark Littlefield |
| | Section Manager MS 1-8 |
| | ADD Regulatory Affairs |
| | [phone] |
| | Fax [phone] |

| Date of Preparation of this Summary: | May 13, 1998 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Device Trade or Proprietary Name: | Amm Cal, Bil Cal, CO2 Cal,<br>HDL Cal, Iron/Mg Cal, LDL Cal,<br>MC Cal, UPro Cal, and ISE<br>Calibrator Levels 1 and 2. |

Device Common/Usual Name or Classification Name: Abbott Clinical Chemistry Calibrators

Classification Number/Class: Class II

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: _______________________________________________________________________________________________________________________________________________

## Intended Use:

The Ammonia Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Ammonia.

The Bilirubin Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Bilirubin.

The Carbon Dioxide Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Carbon Dioxide.

The HDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for HDL.

Abbott Calibrators 510(k) May 13, 1998 Calibrator 510k.lwp

Section I Page 1

## 0000010

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The Iron/Magnesium Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Iron and Magnesium.

The LDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for LDL.

The MC Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Albumin, Calcium, Cholesterol, Creatinine, Glucose, Phosphorus, Total Protein, Triglyceride, Urea Nitrogen, and Uric Acid.

The UPro Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for protein in urine and CSF.

The ISE Calibrator Levels 1 and 2 are intended for in vitro diagnostic use in clinical chemistry assays for Sodium, Potassium, and Chloride.

Conclusion: Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k) as outlined on the next page.

bbott Calibrators 510(k) May 13, 1998 Calibrator Sick lwo

Section I Page 2

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| Calibrator Name | Reagent Name | Reagent 510(k)<br>Number |
|----------------------------------------|---------------------------------|--------------------------|
| Ammonia Calibrator | Ammonia | K981467 |
| Liquid Bilirubin Calibrator | Total Bilirubin | K981336 |
| | Direct Bilirubin | K981222 |
| Carbon Dioxide Calibrator | Carbon Dioxide | K981231 |
| HDL Calibrator | Direct HDL | K981224 |
| Iron/Magnesium<br>Calibrator | Iron | K981241 |
| | Magnesium | K981192 |
| LDL Calibrator | Direct LDL | K981303 |
| ISE Calibrator Levels I<br>and Level 2 | Sodium<br>Potassium<br>Chloride | K974779 |
| Multiconstituent<br>Calibrator | Albumin BCG | K981468 |
| | Albumin BCP | K981457 |
| | Calcium | K981232 |
| | Cholesterol | K981476 |
| | Creatinine | K981240 |
| | Glucose | K981185 |
| | Phosphorus | K981118 |
| | Total Protein | Exempt Class II |
| | Triglyceride | K981223 (Exempt Class I) |
| | Urea Nitrogen | K981123 |
| | Uric Acid | K981189 |
| Urine/CSF Protein<br>Calibrator | Urine/CSF Protein | K981295 |

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Section I
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 0 1098

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981706 Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and ISE Calibrator Levels 1 and 2 Regulatory Class: II Product Code: JIX Dated: May 13, 1998 Received: May 14, 1998

Dear Mr. Littlefield:

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 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 reqistration, 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 Requlation (QS) for Medical Devices: General regulation (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 requlation may result in requlatory 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.

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This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding 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 [phone] or [phone] or at its internet address "[e-mail]".

Sincerely yours,

Steven Autman

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: _ Abbott Clinical Chemistry Calibrators

Indications For Use:

An Abbott Clinical Chemistry 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.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k981706

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)