SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD

K971333 · Beckman Instruments, Inc. · JIX · May 23, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971333
• Device Name: SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD
• Applicant: Beckman Instruments, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems ~- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

Device Story

SYNCHRON Systems Enzyme Reagents (ALP, CHE, GGT, LD) and Enzyme Validator Set are in vitro diagnostic reagents for use on Beckman SYNCHRON Clinical Systems. Reagents react with human serum or plasma samples to measure specific enzyme activity. The Enzyme Validator Set provides reference points to calibrate assays, ensuring results are compatible with IFCC or DGKCh standardized methods. Used in clinical laboratory settings by trained personnel. Output is quantitative enzyme activity levels, aiding clinicians in diagnosing and monitoring liver, bone, parathyroid, and intestinal diseases, or managing poisoning cases. Benefits include standardized, accurate enzyme measurement across clinical platforms.

Clinical Evidence

Bench testing only. Performance demonstrated via method comparison studies (n=67-80 samples per reagent) comparing calibrated vs. uncalibrated methods, showing high correlation (r=0.996-0.999). Imprecision studies (n=80) conducted for all reagents across multiple levels, reporting %C.V. values ranging from 0.42% to 16.01% (highest at low-level GGT).

Technological Characteristics

In vitro diagnostic reagents for automated clinical chemistry analyzers. Reagents utilize standard enzymatic reaction principles. Calibration is performed using the Enzyme Validator Set to align with IFCC/DGKCh reference methods. System is designed for use on Beckman SYNCHRON Clinical Systems.

Indications for Use

Indicated for quantitative determination of ALP, CHE, GGT, and LD enzyme activity in human serum or plasma for diagnosis and treatment of liver, bone, parathyroid, intestinal, and cholinesterase inhibition disorders (e.g., insecticide/succinylcholine poisoning).

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

• SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent (K881498)
• SYNCHRON Systems Cholinesterase (CHE) Reagent (K893583)
• SYNCHRON Systems y-Glutamyl Transferase (GGT) Reagent (K881498)
• SYNCHRON Systems Lactate Dehydrogenase (LD) Reagent (K881498)
• SYNCHRON Enzyme Validator Set (K951964)

Submission Summary (Full Text)

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K971333

MAY 23 1997

Summary of Safety & Effectiveness SYNCHRON Systems Enzyme Reagents and Enzyme Validator

#### 1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

8 May 1997

#### 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON® Systems Alkaline Phosphatase (ALP) Reagent SYNCHRON® Systems Cholinesterase (CHE) Reagent SYNCHRON® Systems y-Glutamyl Transferase (GGT) Reagent SYNCHRON® Systems Lactate Dehydrogenase (LD) Reagent SYNCHRON® Enzyme Validator Set

#### 3.2 Classification Name

Alkaline Phosphatase or isoenzymes test system (21 CFR § 862.1050) Cholinesterase test system (21 CFR § 862.3240) Gamma-glutamyl transpeptidase and isoenzymes test system (21 CFR § 862.1360) Lactate Dehydrogenase test system (21 CFR § 862.1440) Calibrator (21 CFR § 862.1150)

enz_510k.sse

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#### 4.0 Predicate Device(s):

| SYNCHRON Reagent | Predicate | Predicate Company | Docket<br>Number |
|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------|------------------|
| SYNCHRON Systems<br>Alkaline Phosphatase<br>(ALP) Reagent | SYNCHRON Systems<br>Alkaline Phosphatase<br>(ALP) Reagent | Beckman Instruments<br>Inc. | K881498 |
| SYNCHRON Systems<br>Cholinesterase (CHE)<br>Reagent | SYNCHRON Systems<br>Cholinesterase (CHE)<br>Reagent | Beckman Instruments<br>Inc. | K893583 |
| SYNCHRON Systems<br>y-Glutamyl<br>Transferase (GGT)<br>Reagent | SYNCHRON Systems<br>y-Glutamyl<br>Transferase (GGT)<br>Reagent | Beckman Instruments<br>Inc. | K881498 |
| SYNCHRON Systems<br>Lactate<br>Dehydrogenase (LD)<br>Reagent | SYNCHRON Systems<br>Lactate<br>Dehydrogenase (LD)<br>Reagent | Beckman Instruments<br>Inc. | K881498 |
| SYNCHRON Enzyme<br>Validator Set | SYNCHRON Enzyme<br>Validator Set | Beckman Instruments<br>Inc. | K951964 |

and the comments of the first

1. 11. 11.

:

2

.

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#### 5.0 Description:

The SYNCHRON Systems ALP. CHE, GGT, and LD Reagents are intended for use on Beckman's SYNCHRON Clinical Systems. These reagents may be used in conjunction with the SYNCHRON Enzyme Validator for assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

#### 6.0 Intended Use:

The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems ~- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

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Beckman Instruments, Inc., Section 510(k) Notification Beckman Instruments, The Reagents and Enzyme Validator Summary of Safety & Effectiveness

### Comparison to Predicate(s): 7.0

The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|------------------------------------------------------------|-----------------------|-------------------------------------|
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Intended use | Same as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Chemical Reaction | Same principle as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Reagent Formulation | Same formulations as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Stability | Same as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Interferences | Same as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Anti-Coagulants | Same as the predicates |
| SYNCHRON Systems<br>Enzyme Reagents<br>(ALP, CHE, GGT, LD) | Packaging | Same as the predicates |
| SYNCHRON<br>Enzyme Validator<br>Set | Intended use | Same as the predicate |
| SYNCHRON<br>Enzyme Validator<br>Set | Formulation | Same formulation as predicate |
| SYNCHRON<br>Enzyme Validator<br>Set | Stability | Same as the predicate |
| SYNCHRON<br>Enzyme Validator<br>Set | Packaging | Same as the predicate |

### SIMILARITIES to the PREDICATE

file: enz_510k.sse

4

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| DIFFERENCES from the PREDICATE | | |
|------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent | Aspect/Characteristic | Comments |
| SYNCHRON Systems<br>reagents (ALP, CHE,<br>GGT, LD,) | Calibration | ALP, CHE, GGT, LD are<br>calibrated with Enzyme Validator<br>product and the predicate<br>reagents are not |
| | Standardization to<br>IFCC/DGKCh methods | When ALP, CHE, GGT, LD<br>reagents are calibrated with<br>Enzyme Validator, the assay<br>results are standardized to<br>compatible IFCC/DGKCh<br>methods while assay results from<br>the predicate reagents are not |
| | Reference Ranges | ALP, CHE, GGT, and LD<br>reference ranges may differ from<br>the predicates |
| SYNCHRON Enzyme<br>Validator Set | Value Assignment | SYNCHRON Enzyme Validator in<br>addition to ALT-, AST- CK-, now<br>includes value assignments for<br>ALP, CHE, GGT, and LD assays<br>and the predicate Enzyme<br>Validator only has value<br>assignments for the ALT-, AST-<br>and CK- assays. |

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.

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#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the noncalibrated SYNCHRON Systems Enzyme Reagents and the calibrated SYNCHRON Systems Enzyme Reagents with the associated SYNCHRON Enzyme Validator.

| Reagent | Slope | Intercept | r | n | Predicate<br>Method |
|---------------------------------------------------------------|-------|-----------|-------|----|------------------------------------------------------|
| SYNCHRON<br>LX System<br>Calibrated<br>(DGKCH) ALP<br>Reagent | 1.426 | 3.34 | 0.999 | 67 | SYNCHRON<br>LX System<br>Uncalibrated<br>ALP Reagent |
| SYNCHRON<br>LX System<br>Calibrated<br>(IFCC) ALP<br>Reagent | 1.019 | -1.95 | 0.999 | 79 | SYNCHRON<br>LX System<br>Uncalibrated<br>ALP Reagent |
| SYNCHRON<br>LX System<br>Calibrated<br>CHE Reagent | 0.760 | 2.56 | 0.999 | 72 | SYNCHRON<br>LX System<br>Uncalibrated<br>CHE Reagent |
| SYNCHRON<br>LX System<br>Calibrated<br>GGT Reagent | 1.141 | -2.18 | 0.999 | 79 | SYNCHRON<br>LX System<br>Uncalibrated<br>GGT Reagent |
| SYNCHRON<br>LX System<br>Calibrated LD<br>Reagent | 1.242 | -0.20 | 0.996 | 70 | SYNCHRON<br>LX System<br>Uncalibrated<br>LD Reagent |

# Method Comparison Study Results SYNCHRON Systems ALP, CHE, GGT, LD Reagents

### Estimated Imprecision

SYNCHRON LX Systems ALP Reagent

| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|------------------------|-------------|-------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 39.6 | 1.77 | 4.49 | 80 |
| Level 2 | 147.9 | 2.68 | 1.81 | 80 |
| Level 3 | 258.1 | 1.92 | 0.75 | 80 |
| Total Imprecision | | | | |
| Level 1 | 39.6 | 2.24 | 5.66 | 80 |
| Level 2 | 147.9 | 3.10 | 2.10 | 80 |
| Level 3 | 258.1 | 2.85 | 1.10 | 80 |

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## SYNCHRON LX Systems CHE Reagent

| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|------------------------|------------|------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 2473 | 35.1 | 1.3 | 80 |
| Level 2 | 3330 | 31.9 | 1.0 | 80 |
| Level 3 | 8805 | 85.5 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 2473 | 46.9 | 1.9 | 80 |
| Level 2 | 3330 | 49.2 | 1.5 | 80 |
| Level 3 | 8805 | 157.9 | 1.8 | 80 |

### SYNCHRON LX Systems GGT Reagent

| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|------------------------|-------------|-------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 13.0 | 1.72 | 13.23 | 80 |
| Level 2 | 194.0 | 1.84 | 0.95 | 80 |
| Level 3 | 371.7 | 1.56 | 0.42 | 80 |
| Total Imprecision | | | | |
| Level 1 | 13.0 | 2.08 | 16.01 | 80 |
| Level 2 | 194.0 | 4.25 | 2.19 | 80 |
| Level 3 | 371.7 | 7.90 | 2.13 | 80 |

### SYNCHRON LX Systems LD Reagent

| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|------------------------|-------------|-------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 62.5 | 2.2 | 3.5 | 80 |
| Level 2 | 419.0 | 3.5 | 0.8 | 80 |
| Total Imprecision | | | | |
| Level 1 | 62.5 | 2.8 | 4.5 | 80 |
| Level 2 | 419.0 | 5.3 | 1.3 | 80 |

### Stability Study Results

| Reagent | Product Claim |
|---------------------------|---------------------|
| SYNCHRON Enzyme Validator | 18 month shelf-life |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

file: enz_510k.sse

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with stylized wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 1997

Lucinda Stockert · Senior Requlatory Specialist Beckman Instruments, Inc. --200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000

Re: K971333 SYNCHRON® Systems Enzyme Reagents and Enzyme Validator Regulatory Class: I & II Product Code: CJE, DIH, JPZ, CFJ, JIX Dated: March 28, 1996 Received: April 1, 1996

Dear Ms. Stockert:

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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Page 2

SE III E START FOR

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHA-607) Chird device if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produce, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 compreation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entified, "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 obtained free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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):

SYNCHRON® Systems Alkaline Phosphatase (ALP) Device Name: Reagent

Indications for Use:

The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

21 CFR 862.1050 Alkaline Phosphatase or isoenzymes test system.

(a) Identification. An alkaline phosphatase system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

(b) Classification. Class II.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------|--------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | k971333 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-the-Counter Use ______ |
|----------------------|-----------------------------------------|----|-----------------------------|
| (per 21 CFR 801.109) | | | Optional Format 1-2-96 |

{10}------------------------------------------------

page of

510(k) Number (if known):

SYNCHRON® Systems Cholinesterase (CHE) Reagent Device Name:

Indications for Use:

The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

21 CFR 862.3240 Cholinesterase test system.

(a) Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetyl-choline to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinvicholine poisoning).

(b) Classification. Class I

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96

{11}------------------------------------------------

510(k) Number (if known):

SYNCHRON Systems y-Glutamyl Transferase Reagent Device Name:

Indications for Use:

SYNCHRON Systems y-Glutamyl Transferase (GGT) Reagent, The in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of y-glutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in coniunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

21 CFR 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.

(a) Identification. A gamma-glutamy) transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gammaqlutamy] transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic circhosis and primary and secondary liver tumors.

(b) Classification. Class I.

(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-Counter Use Optional Format 1-2-96

{12}------------------------------------------------

510(k) Number (if known):

Device Name:

11 2 1 2 4 1 2 4 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1

SYNCHRON® Systems Alkaline Phosphatase (ALP) Reagent

Indications for Use:

The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

21 CFR 862.1050 Alkaline Phosphatase or isoenzymes test system.

(a) Identification. An alkaline phosphatase system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

(b) Classification. Class II.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | c971333 |
|---------------|---------|
|---------------|---------|

| Prescription Use (per 21 CFR 801.109) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| Over-the-Counter Use Optional Format 1-2-96 | |
|---------------------------------------------|--|
|---------------------------------------------|--|

{13}------------------------------------------------

page of of

510(k) Number (if known):

SYNCHRON® Systems Cholinesterase (CHE) Reagent Device Name:

Indications for Use:

and and the specifical and the

The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on Use of this product, in conjunction with the SYNCHRON Systems. SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

21 CFR 862.3240 Cholinesterase test system.

(a) Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetyl-choline to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

(b) Classification. Class I

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺮ (per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96