BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

K012340 · Bayer Corp. · JMO · Oct 1, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012340
• Device Name: BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
• Applicant: Bayer Corp.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

This in vitro diagnostic procedure is intended to measure iron-binding capacity in human serum. Such measurement is used in the diagnosis and treatment of anemia.

Device Story

The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic test performed on the Bayer ADVIA IMS system. It measures iron-binding capacity in human serum samples. The device is intended for use in clinical laboratory settings by trained personnel. The assay provides quantitative results that assist clinicians in diagnosing and monitoring patients with anemia. The system processes serum samples to determine UIBC levels, which are then used to inform clinical decision-making regarding iron status and anemia management.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies and method comparison. Precision studies showed total CVs ranging from 1.0% to 10.6% across levels 48.0-537 ug/dL. Method comparison against the predicate (CHEM 1) yielded a correlation coefficient (R) of 0.997 (N=58) with a regression equation of Y=0.96X-8.76. Analytical range established at 30 to 560 ug/dL. Interference data provided for bilirubin and lipids.

Technological Characteristics

In vitro diagnostic assay for use on the Bayer ADVIA IMS automated chemistry analyzer. Analytical range: 30-560 ug/dL. Methodology involves spectrophotometric measurement of iron-binding capacity in serum. System is a clinical laboratory instrument.

Indications for Use

Indicated for the measurement of iron-binding capacity in human serum to aid in the diagnosis and treatment of anemias.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• Technicon CHEM 1

Submission Summary (Full Text)

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# OCT - 1 2001

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Unsaturated Iron Binding Capacity (UIBC) method for ADVIA® IMS™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: HQ10340

## 1. Intended Use

This in vitro diagnostic procedure is intended to measure iron-binding capacity in human Such measurement is used in the diagnosis and serum.on the Bayer ADVIA® IMS™. treatment of anemia.

### 2. Predicate Device

| The Research As and Children Company of Children Comments of Children Comments of<br>Product Name | | agent Part # Calibrator Part # |
|---------------------------------------------------------------------------------------------------|-------------------------|----------------------------------|
| Technicon CHEM<br>t | T01-1869-53 T03-1291-62 | |

## 3. Device / Method

| Product Name | REF | Calibrator Part # |
|-----------------|----------|-------------------|
| Bayer ADVIA IMS | 06254177 | T03-1291-62 |

### A. Imprecision

| | ADVIA IMS | | CHEM 1 | |
|--|------------------|----------------|------------------|----------------|
| | Level<br>(ug/dL) | Total<br>CV(%) | Level<br>(ug/dL) | Total<br>CV(%) |
| | 48.0 | 10.6 | 141 | 5.3 |
| | 157 | 3.4 | 306 | 6.3 |
| | 537 | 1.0 | 559 | 4.5 |

#### Correlation (Y=ADVIA IMS, X=comparison system)

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (ug/dL) | R | Sample Range (ug/dL) |
|---------------------|-----------------------|----|---------------------|-------------|-------|----------------------|
| Serum | CHEM 1 | 58 | $Y=0.96X-8.76$ | 7.86 | 0.997 | 41.5 - 538.0 |
| Plasma(y), Serum(x) | ADVIA IMS | 50 | $Y=0.99X-1.70$ | 3.04 | 0.999 | 114.1 - 438.9 |

#### Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | UIBC Conc<br>(ug/dL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|----------------------|----------------------|
| Bilirubin (unconjugated) | 12.5 | 212.7 | -10 |
| Bilirubin (conjugated) | 12.5 | 208.2 | -5 |
| Lipids (Triglycerides) | 250 | 211.7 | -69 |

#### Analytical Range

Serum/Plasma: 30 to 560 ug/dL

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Alexis

7/20/01

Freerick Clerie
Manager Regulatory Affairs Bayer Corporation
511 Benedict Avenue Tarrytown, New York 10591-5097

Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 1 2001

Kenneth T. Edds, Ph.D. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k012340

Trade/Device Name: ADVIA IMS® Unsaturated Iron binding Capacity (UIBC) Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JMO Dated: July 19, 2001 Received: July 24, 2001

Dear Dr. Edds:

We have reviewed your 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to prox co ria) 2011-03-2014 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 letter will anow you to ocen marketing , o walence of your device to a legally marketed notification. The PDA inding of successification 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 (2) CFF Part 801 and 1 II you desire specific acrico roll "see are contact the Office of Compliance at additionally 809.10 for in vius diagliostions on the promotion and advertising of your device, [phone]. Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranding by reference to precise to precised from the Division of Small information on your responsionales and Consumer Assistance at its toll-free number [phone] or Manufacturers International and October "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Page 1 of 1

510(k) Number (if known): KO12340

Device Name: ADVIA IMS® Unsaturated Iron binding Capacity (UIBC)

Indication For Use:

The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|-----------------------------|
| Prescription Use | OR | Over-The-Counter Use ______ |
| (Per 21 CFR 801.109) | | |

*(Division Sign-Off)*

Kevin Alexander Johnston Optional Formal 1-2-96

Division of Clinical Laboratory Devices

| 510(k) Number | K012340 |
|---------------|---------|
|---------------|---------|