PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS

K024182 · Precision Systems, Inc. · CDQ · Mar 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024182
• Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
• Applicant: Precision Systems, Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

Device Story

The ANALETTE is an open-system, automated clinical chemistry analyzer used in laboratory settings. It accepts liquid samples (serum, plasma, urine) and processes them using user-selected, commercially manufactured reagents. The device performs data collection, data reduction, and instrument operation to measure analytes and enzymes. It is operated by laboratory personnel. Output is provided to healthcare providers to assist in monitoring physiological diseases or conditions. The system is functionally identical to the predicate Synermed IR 200/ANALETTE, utilizing established chemistry methodologies to provide quantitative results.

Clinical Evidence

Bench testing only. Imprecision studies (within-run and total) performed over 20 days using control serums. Correlation studies performed on ~100 serum samples comparing STANBIO reagents against Synermed/MAS reagents; results showed acceptable slopes, intercepts, and correlation coefficients. Linearity and recovery studies confirmed performance within manufacturer claims. No clinical patient data required.

Technological Characteristics

Automated microchemistry analyzer; open system architecture. Performs quantitative photometric analysis of liquid samples. Compatible with various third-party reagents. No specific materials of construction or software architecture details provided beyond classification as an automated clinical chemistry analyzer.

Indications for Use

Indicated for quantitative determination of various analytes (e.g., enzymes, electrolytes, metabolites) in human serum, plasma, or urine to monitor physiological diseases or conditions. No specific age or gender restrictions stated.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Predicate Devices

• Precision Systems, Inc. ANALETTE using Synermed Reagents (K013654)
• Precision Systems, Inc. ANALETTE using Medical Analysis Systems Inc. Reagents (K022072)

Reference Devices

• Hitachi 705

Submission Summary (Full Text)

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KC24182

MAR 0 3 2003

# Precision Systems ", Inc ™ ANALETTE /STANBIO Reagents 510 (k)

### 1. Submitted by:

Precision Systems™, Inc. 16 Tech Circle Natick MA. 01748 Establishment Reg'n No. 1250003 Attention: Bill Haden

### 2. Product Name:

# A. Proprietary Name:

Precision Systems™ ANALETTE™ Chemistry Analyzer STANBIO Laboratorys Reagents

#### B. Classification Name:

Chemistry analyzer, micro, for clinical use, 75JJF Common or Usual Name: Chemistry analyzer (Class I) STANBIO Laboratory Reagents Calcium Test System (Class II) CJY 21 Creatinine Test System (Class II) CGX 21 Phosphorus Test System (Class I) CEO 21 Albumin Test System (Class II) CIX 21 Total Protein Test System (Class II) CEK 21 Glucose Test System (Class II) CGA 21 Urea Nitrogen Test System (Class II) CDQ 21 Magnesium Test System (Class I) JGJ 21 Creatine Kinase Test System (Class II) CGS 21 Alkaline Phosphatase Test System (Class II) CJE 21 Cholesterol(included HDL) Test System (Class I) CHH 21 Triglycerides Test System (Class I) JGY 21 Total Bilirubin Test System (Class II) CIG 21 Direct Bilirubin Test System (Class II) CIG 21 Uric Acid Test System (Class II) KNK 21 Lactate Dehydrogenase L Test System (Class II) CFJ 21 Alanine Aminotransferase Test System (Class II) CKA 21

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Aspartate Aminotransferase Test System (Class II) CIT 21 Gamma Glutamyl Transferase Test System (Class I) JQB 21 Chloride Test System (Class I)

### 3. Intended Use:

The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glycose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin. Uric Acid. Lactate Dehydrogenase L. Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. .

# 4. Classification:

The FDA has classified Microchemistry analyzer for clinical use as Class I as published in the Federal Register of May 1, 1987, section 862.2170. FDA has classified Enzyme analyzer for clinical use as Class I as published in the Federal Register of May 1, 1987, section 862.2500. The FDA has classified Calcium, Creatinine, Albumin, Total Protein, Glucose, Urea Nitrogen, Creatine Kinase, Alkaline Phosphatase, Total Bilirubin, Direct Bilirubin, Lactate Dehydrogenase L. Lactate. Aspartate Aminotransferase test systems into Class II (performance Standards). Gamma Glutamyl Transferase, Phosphorus, Magnesium, Cholesterol(includes HDL), Triglycerides, Uric Acid, Alanine Aminotransferase, and. Chloride test systems into Class I.

### 5. Compliance with Section 514

Performance specifications: None established under Section 514.

### 6. Labeling:

ANALETTE™ Application Sheets: Exhibit A Synermed Chemistry inserts/applications sheets IR 200/ ANALETTE ™ and Medical Analysis Systems inserts: Exhibit B STANBIO Laboratory inserts: Exhibits C Distribution of STANBIO Reagents with the Analette will be under STANBIO Laboratory Labeling except with the PSI inserts (application data sheets)

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### 7. Substantial Equivalence:

Exhibit D. Precision Systems™ approved 510k K013654 for the ANALETTE™ using Synermed® Reagents and Precision Systems™ approved 510k K022072 for the ANALETTE ~ using Medical Analysis Systems Inc® Reagents. Exhibit E. Acceptance Criteria. Exhibit F. Acceptance Criteria Exhibit G. Data

# Chemistry Classification and 510k Numbers

| Chemistry | Synermed<br>510 k | Class | STANBIO<br>510k | Section |
|----------------------------|-------------------|-------|-------------------------------|----------|
| Calcium | 953395 | II | Mkted prior 5/76 | 862.1145 |
| Creatinine | 943924 | II | 771856 | 862.1225 |
| Phosphorus | 912569 | I | 800297 | 862.1580 |
| Albumin | 903543 | II | 771771 | 862.1035 |
| Total Protein | 903511 | II | Mkted prior 5/76 | 862.1635 |
| Glucose | 903063 | II | 832159 | 862.1345 |
| Urea Nitrogen | 911248 | II | 962418 | 862.1770 |
| Magnesium | 902919 | I | 883170 | 862.1495 |
| Creatine Kinase | 930932 | II | 972155 | 862.1215 |
| Alkaline Phosphatase | 931986 | II | 941313 | 862.1050 |
| Cholesterol(includes HDL) | 903015 | I | 831863 | 862.1175 |
| Triglycerides | 903016 | I | 831858 | 862.1705 |
| Uric Acid | 923414 | I | 831864 | 862.1775 |
| Lactate Dehydrogenase L | 921025 | II | Exempt 11/98<br>(63 FR 59225) | 862.1440 |
| Alanine Aminotransferase | 921016 | II | 941314 | 862.1030 |
| Aspartate Aminotransferase | 915555 | II | 932049 | 862.1100 |
| Gamma Glutamyl Transferase | 931958 | I | 941315 | 862.1360 |
| Chloride | 903103 | I | 781635 | 862.1170 |
| Total Bilirubin | 861413 | II | 810055 | 862.1110 |
| Direct Bilirubin | 900259 | II | 810055 | 862.1110 |

- A. Introduction: The ANALETTE ~, 510k Number K013654, is the Synermed® IR 200, 510k Number K971491, and uses the above Synermed® reagents with each of their above 510k numbers. Medical Analysis Systems' reagents have all also been 510k'ed with the noted above 510k numbers. STANBIO Laboratory's reagents have all also been 510k'ed with the noted above 510k

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numbers. The use of STANBIO Laboratory's Reagents should also be classified in Class I as has Synermed and MAS reagents on the ANALETTE™.

- B. Overview: Precision Systems™ Inc. at 16 Tech Circle. Natick MA. 01760 manufactures The ANALETTE™. It has been commercially available as the IR 200 with Synermed® reagents since April 1997. It has been commercially available as the Analette with Synermed® reagents since June 2002. It has been commercially available as the Analette with Medical Analysis Systems' reagents since August 2002.
- C. The Precision Systems™ Inc. ANALETTE musing STANBIO Laboratory's Reagents should be classified Class I as published in the Federal Register of May 1, 1987, section 862.2170 because for the purpose of the Act, it is substantially equivalent to the Synermed® IR 200/ ANALETTE™ using Synermed and MAS reagents and therefore the Hitachi® 705, both products in commercial distribution.
- D. Comparison to the Predicate Product: EQUIVALENCE:

The Precision Systems Inc. ANALETTE™ is identical to the Synermed® IR 200(OEM'ed to Synermed®) product in commercial using Synermed® reagents. The ANALETTE m is an open system and is intended for use in conjunction with certain materials (Synermed® reagents, Medical Analysis Systems' reagents, STANBIO Laboratory reagents, or etc.) to measure a variety of analytes and enzymes found in human serum, plasma, urine, spinal fluid, etc. All data collection, data reduction, and instrument operation for the ANALETTE™ using Synermed® and MAS reagents are the same as that used for STANBIO Laboratory reagents. Application parameters may vary depending on optimization or manufactures insert suggested parameters.

#### DIFFERENCES:

The ANALETTE ™ is an open system and currently has been FDA approved for use with Synermed® and Medical Analysis reagents. Synermed® reagents, Medical Analysis Systems reagents, and STANBIO Laboratory reagents are approved to be used on open systems. STANBIO Laboratory reagents are not currently approved for use on or distribution with the ANALETTE™.

- E. Chemistry Methodologies:
Synermed® and MAS chemistries that have been 510k approved on the Synermed® IR200 and/ or the ANALETTE™. Their methodology is shown in their respective insert Exhibit B. STANBIO Laboratory reagents have been 510k approved for use on an open system. Their methodology is shown in their respective insert Exhibit C

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#### F. Procedures:

Imprecision: Two control serums were used to carry out the determination of within run and total precision of each Synermed® and Medical Analysis Systems reagents and the STANBIO Laboratory Reagents. Each sample was measured in duplicate for up to 20 days for total precision. Similarly, within run precision was determined with up to 20 repeats of two control serums to eliminate reagent preparation variance, control serum drift, and repeated calibrations.

Correlation: Samples were assayed for correlation as part of the Imprecision procedure using each of Synermeds® reagents and Medical Analysis Systems Reagents, and STANBIO Laboratory Reagents A comparison is made between the two Commercial reagents run on the ANALETTE™ using Synermeds® or Medical Analysis Systems reagents as the reference.

Linearity: Commercially available linearity material was assayed and Least Square linear regression was used to determine expected linearity. A comparison is made between STANBIO Laboratory Reagents and the Least Square line to establish the linearity.

Recovery: Commercial available Controls with assigned values for Medical Analysis Systems Reagents were used to determine recovery, which was conducted as part of the imprecision study.

- G. Results:
Imprecision: Results in Table 1 and Table 2 vs insert values indicate that serum controls give acceptable/equivalent results using the described procedure for within run and total imprecision with each of the representative test methods.

Correlation: Results obtained with about 100 serums using each of the Synermeds® or Medical Analysis Systems Reagents as the reference tests were compared to those with STANBIO Laboratory Reagents. Slopes, Intercepts and Correlation Coefficients show acceptable results. The regression(slope and intercept) and correlation coefficients are shown in Table 3 and Graphs 1-21. Acceptable results are shown between both methods.

Linearity results are shown in Table 4 vs insert values. Linearity did not exceed the Manufacturers' claim.

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Recovery results using assigned control serums ranges are shown in Table 5. Acceptable results are shown between both methods.

No modifications have been made in the STANBIO Laboratory Reagents nor packaging, therefore, the Normal Range, Sensitivity, and Stability will remain as recommended by the manufacture. The above data support equivalence; therefore, these parameters were not tested.

# H. Conclusions:

For the above reasons, we believe the ANALETTE ~ clinical chemistry analyzer using STANBIO Laboratory Reagents to be substantially equivalent to the ANALETTE™ clinical chemistry using Synermeds® or Medical Analysis Systems Reagents.

Should you require further information or have questions, please contact me at: 508 655 7010. Bill Haden

Summary of Safety and Effectiveness: June 14, 2002

Manufacturer:

Precision Systems™, Inc. 16 Tech Circle Natick, MA. 01760 Attention: Bill Haden

STANBIO Laboratory, Inc 1261 North Main Street Boerne, Texas 78006-3014

Proprietary Name:

ANALETTE TM STANBIO Laboratory Reagents: Calcium, Creatinine Phosphorus Albumin Total Protein Glucose Urea Nitrogen Magnesium Creatine Kinase Alkaline Phosphatase Cholesterol(includes HDL) Triglycerides Total Bilirubin Direct Bilirubin Uric Acid

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Lactate Dehydrogenase L Alanine Aminotransferase Aspartate Aminotransferase Gamma Glutamyl Transferase Chloride

:

Classification

.

.

| Classification | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|----------|
| Name: | Chemistry analyzer, micro | 862.2500 |
| | Calcium | 862.1145 |
| | Creatinine | 862.1225 |
| | Phosphorus | 862.1580 |
| | Albumin | 862.1035 |
| | Total Protein | 862.1635 |
| | Glucose | 862.1345 |
| | Urea Nitrogen | 862.1770 |
| | Magnesium | 862.1495 |
| | Creatine Kinase | 862.1215 |
| | Alkaline Phosphatase | 862.1050 |
| | Cholesterol(includes HDL) | 862.1175 |
| | Triglycerides | 862.1705 |
| | Total Bilirubin | 862.1110 |
| | Direct Bilirubin | 862.1110 |
| | Uric Acid | 862.1775 |
| | Lactate Dehydrogenase L | 862.1440 |
| | Alanine Aminotransferase | 862.1030 |
| | Aspartate Aminotransferase | 862.1100 |
| | Gamma Glutamyl Transferase | 862.1360 |
| | Chloride | 862.1170 |
| Intended Use: | An in vitro diagnostic automated clinical chemistry<br>analyzer for the analysis of analytes in solution. | |
| Predicate Device: | Precision Systems™, Inc, ANALETTE™ using<br>Synermeds® or Medical Analysis Systems reagents. | |
| Performance: | Substantially equivalence was established in<br>comparative studies. | |
| | It was concluded from these results that this product<br>is safe and effective. | |
| Safe Medical<br>Device Act 1990 | Precision Systems™ will make any additional safety<br>and effectiveness information for the ANALETTE ™ | |
| | Clinical Chemistry Analyzer available to interested | |
| | persons upon request. | |

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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 0 3 2003

Mr. Bill Haden VP Scientific and Regulatory Affairs Precision Systems, Inc. 16 Tech Circle Natick, MA 01760

Re: k024182

Trade/Device Name: Precision Systems Analette Chemistry Analyzer & Stanbio Laboratory Reagents Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ; CEO; CGA; CGS; CGX; CHH; CHJ; CIG; CIT; CIX; CJE; CJY; JGJ; JGY; JJF; KNK Dated: December 19, 2002 Received: December 19, 2002

Dear Mr. Haden:

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# PRODUCT: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & STANBIO Laboratory REAGENTS

# INDICATIONS FOR USE STATEMENT

The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

Bill Haden, Vice President December 16. 2002

Cear Cooper

ivision Sign=Off) Sivision of Cliffeal Laboratory Devices 510(k) Number = 1 0 24/82

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