ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K020792 · Bayer Diagnostics Corp. · LDP · Jul 11, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020792
• Device Name: ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
• Applicant: Bayer Diagnostics Corp.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.

Device Story

In-vitro diagnostic assay for ADVIA® IMS™ system; measures acetaminophen concentration in human serum or plasma samples. Used in clinical laboratory settings by trained personnel to diagnose acetaminophen toxicity and overdose. Assay provides quantitative results used by clinicians to assess liver damage risk and guide treatment decisions. Benefits include rapid identification of overdose, enabling timely clinical intervention.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies (n=multiple levels, CV% 1.3-2.6%) and method comparison against Abbott TDX (n=46, R=0.999, slope 1.05) and plasma/serum equivalence (n=50, R=0.998, slope 1.00). Analytical range 0-20 mg/dL. Interference testing performed for bilirubin, hemoglobin, and lipids.

Technological Characteristics

In-vitro diagnostic reagent assay for use on ADVIA® IMS™ automated analyzer. Analytical range 0-20 mg/dL. Compatible with human serum and lithium heparin plasma. Standard clinical chemistry analyzer methodology.

Indications for Use

Indicated for measuring acetaminophen levels in human serum or plasma (lithium heparin) to aid in the diagnosis of acetaminophen toxicity and overdose.

Regulatory Classification

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Predicate Devices

• Abbott TDX (K840941)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Acetaminophen method for ADVIA® IMSTM

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: KOZO 792

### 1. Intended Use

This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.

### 2. Predicate Device

| Product Name | | Calibrator<br>- |
|--------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anhott/TTT | APA C CO<br>A | 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000<br>002 |

### 3. Device / Method

| Product Name | Reagent BAN | Calibrator BAN |
|-----------------|-------------|----------------|
| Bayer ADVIA IMS | 01352146 | 04919015 |

#### Imprecision (Serum)

| ADVIA IMS | |
|------------------|----------------|
| Level<br>(mg/dL) | Total<br>CV(%) |
| 1.5 | 2.6 |
| 5.0 | 1.5 |
| 14.9 | 1.3 |

| Abbott/TDx | |
|------------------|----------------|
| Level<br>(mg/dL) | Total<br>CV(%) |
| 1.5 | 4.9 |
| 3.5 | 3.0 |
| 15 | 3.9 |

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

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
|---------------------|-----------------------|----|---------------------|-------------|-------|----------------------|
| Serum | Abbott/TDx | 46 | $Y=1.05X - 0.25$ | 0.31 | 0.999 | 0.3-19.3 |
| Plasma(y), Serum(x) | ADVIA IMS | 50 | $Y=1.00X + 0.05$ | 0.32 | 0.998 | 2.3-17.3 |

#### Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Acetaminophen Conc<br>(mg/dL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|-------------------------------|----------------------|
| Bilirubin (unconjugated) | 25 | 5.7 | +9 |
| Bilirubin (conjugated) | 25 | 5.7 | +4 |
| Hemoglobin | 1000 | 5.5 | -4 |
| Lipids (Triglycerides) | 500 | 5.6 | -9 |

#### Analytical Range

Serum/Plasma: 0 to 20 mg/dL

{1}------------------------------------------------

## 4. Conclusion

Performance of the ADVIA IMS Acetaminophen Assay on a Bayer ADVIA® IMS™ is equivalent to the performance of the Acetaminophen Assay on the predicate device (Abbott TDX, K840941) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.

Kenneth M. Gibbs

2/28/02

Date

Kenpeth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white. There is a logo to the left of the text.

Food and Drug Administration 2098 Gaither Road. Rockville MD 20850

# JUL 11 2002

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

k020792 Re:

> Trade/Device Name: Acetaminophen Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: June 19, 2002 Received: June 20, 2002

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 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.

{3}------------------------------------------------

Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmamain.html".

Sincerely yours,

Steven Butman

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

{4}------------------------------------------------

#### KO20792 510(k) Number:

Device Name: Acetaminophen Assay for the ADVIA® IMSTM

## Indications for Use:

The Bayer ADVIA IMS Acetaminophen method is an in vitro diagnostic device intended to measure acctaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020792

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-CounterUse_

(Optional Format 1-2-96)