DRI-STAT ACID PHOSPHATASE REAGENT

K053612 · Beckman Coulter, Inc. · CKB · Apr 26, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053612
• Device Name: DRI-STAT ACID PHOSPHATASE REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: CKB · Clinical Chemistry
• Decision Date: Apr 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1020
• Device Class: Class 2

Intended Use

Dri-Stat Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON Systems.

Device Story

Dri-STAT® ACP Reagent is an in vitro diagnostic reagent kit for measuring total and non-prostatic acid phosphatase in human serum. The kit includes reagent bottles and acetate buffer, which are manually transferred into a Beckman Coulter User-Defined Cartridge for use on SYNCHRON® Systems. The device functions by reacting with serum samples to produce a measurable change in absorbance at 410 nm, which is then used to quantify acid phosphatase levels. The system is intended for use in clinical laboratory settings by trained personnel. Results are used by healthcare providers to assess patient acid phosphatase levels, aiding in clinical decision-making related to relevant disease states. The device provides an automated analytical method for serum testing, offering a standardized approach to enzyme quantification compared to manual or older platform-based methods.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP-5A (20 days, 2 runs/day). Linearity evaluated across 7 levels (2.0-38.0 ug/ml). Method comparison (Deming regression) performed against predicate on 94 samples for total ACP and 47 samples for non-prostatic ACP, showing high correlation (R ≥ 0.980). Analytical specificity tested against bilirubin, Intralipid, and hemoglobin. A small verification study (n=40) confirmed results fell within literature-cited reference ranges.

Technological Characteristics

In vitro diagnostic reagent kit containing acetate buffer and reagents for acid phosphatase determination. Operates via spectrophotometric analysis at 410 nm. Designed for use as a User-Defined Reagent (UDR) on SYNCHRON® Systems. Analytical range: 2–38 U/L. Reaction volumes: 25 µL sample, 200 µL reagent, 6 µL sample treatment.

Indications for Use

Indicated for the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum. For prescription use on Synchron Systems CX and LX.

Regulatory Classification

Identification

An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

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

• Dri-STAT® Reagent ACP on Cobas Fara (k821674)

Submission Summary (Full Text)

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K053612

### 510(k) Summary Dri-STAT® ACP Reagent

#### 1.0 Submitted By:

APR 26 2006

Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

December 23, 2005

#### 3.0 Device Name(s):

### 3.1 Proprietary Names Dri-STAT® ACP Reagent

### Classification Name 3.2 Acid phosphatase (total or prostatic) test system (21 CFR § 862.1020)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|-------------------------------------------------|-------------------------------------------|---------------------------|------------------|
| Dri-STAT® Reagent<br>ACP on Synchron<br>Systems | Dri-STAT® Reagent<br>ACP On Cobas<br>Fara | Beckman<br>Coulter, Inc.* | K821674 |

*Beckman Coulter, Inc., Brea, CA

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#### 5.0 Description:

The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.

#### 6.0 Intended Use:

Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

#### 7.0 Comparison to Predicate(s):

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

| Similarities | |
|------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | Same as Beckman Coulter |
| Methodology | Dri-STAT® ACP Reagent, |
| Reactive Ingredients | on Cobas Fara |
| Sample Types | |
| Shelf Life | |
| Reaction Type | |
| Differences | |
| Instrument Platforms | Cobas Fara (Predicate) vs. |
| | Synchron® Systems (candidate) |
| Reference Intervals @ 37°C<br>Total Acid Phosphatase<br>(TACP) | ≤5.4 U/L male on predicate<br>2.5-11.7 U/L male per literature |
| Reference Intervals @ 37°C<br>Non-prostatic Acid<br>Phosphatase (NPAP) | ≤1.2 U/L male on predicate<br>0.2-3.5 U/L male per literature |
| Wavelength | 405 nm on predicate |
| | 410 nm on candidate |
| Analytical Range | Predicate: 0 - 38 U/L |
| | Candidate: 2 - 38 U/L |
| Reaction Volumes | 0.20; 3.00; 0.025 mL on predicate |
| | 25; 200; 6 µL on candidate |

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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, linearity, and imprecision experiments.

| Candidate Method | Sample<br>Type | Slope | Inter-<br>cept | R | n | Predicate Method |
|------------------------------------------------------|----------------|-------|----------------|-------|----|------------------------------------------|
| Dri-STAT<br>Reagent ACP<br>On Synchron LX<br>Systems | Serum<br>TACP | 1.093 | 0.143 | 0.994 | 94 | Dri-STAT<br>Reagent ACP<br>On Cobas Fara |
| Dri-STAT<br>Reagent ACP<br>On Synchron LX<br>Systems | Serum<br>NPAP | 1.066 | -0.197 | 0.979 | 47 | Dri-STAT<br>Reagent ACP<br>On Cobas Fara |
| Dri-STAT<br>Reagent ACP<br>On Synchron CX<br>Systems | Serum<br>TACP | 1.075 | 0.460 | 0.997 | 94 | Dri-STAT<br>Reagent ACP<br>On Cobas Fara |
| Dri-STAT<br>Reagent ACP<br>On Synchron CX<br>Systems | Serum<br>NPAP | 1.088 | -0.172 | 0.994 | 47 | Dri-STAT<br>Reagent ACP<br>On Cobas Fara |

Dri-STAT Reagent ACP Method Comparison Study Results

# Dri-STAT Reagent ACP Estimated Imprecision - TACP

| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|------------------------|------------|------------|-------|----|
| Within-Run Imprecision | | | | |
| Serum Control 1 | 3.81 | 0.18 | 4.72 | 80 |
| Serum Control 2 | 20.6 | 0.26 | 1.28 | 80 |
| Serum Control 3 | 37.0 | 0.50 | 1.35 | 80 |
| Human Pool | 35.5 | 0.58 | 1.63 | 80 |
| Total Imprecision | | | | |
| Serum Control 1 | 3.81 | 0.19 | 4.99 | 80 |
| Serum Control 2 | 20.6 | 0.35 | 1.70 | 80 |
| Serum Control 3 | 37.0 | 0.64 | 1.73 | 80 |
| Human Pool | 35.5 | 0.91 | 2.56 | 80 |

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| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|------------------------|------------|------------|-------|----|
| Within-Run Imprecision | | | | |
| Serum Control 1 | 2.60 | 0.21 | 8.08 | 80 |
| Human Pool | 2.96 | 0.24 | 8.11 | 80 |
| Total Imprecision | | | | |
| Serum Control 1 | 2.60 | 0.21 | 8.08 | 80 |
| Human Pool | 2.96 | 0.29 | 9.80 | 80 |

Dri-STAT Reagent ACP Estimated Imprecision - NPAP

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.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-110 Brea, CA 92822-8000

APR 2 6 2006

Re: k053612

Trade/Device Name: Dri-STAT® Reagent ACP Regulation Number: 21 CFR§862.1020 Regulation Name: Acid Phosphatase (total or prostatic) test system Regulatory Class: Class II Product Code: CKB Dated: March 22, 2006 Received: March 23, 2006

Dear Mr. Hirumi:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/industry/support/index.html.

Sincerely yours.

Albert Gutt

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K053612

Dri-STAT® REAGENT ACP Device Name:

Indications For Use:

Reagent ACP is intended for use in the in vitro diagnostic Dri-STAT® determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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K053612