(58 days)
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, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, 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 and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ANALETTE™ clinical chemistry analyzer and Medical Analysis Systems Reagents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a submission for substantial equivalence (510(k)) for the ANALETTE™ clinical chemistry analyzer using Medical Analysis Systems (MAS) Reagents, comparing it to the same ANALETTE™ analyzer using Synermeds® 072 reagents (the predicate device). The core of the acceptance criteria here is the demonstration of "substantial equivalence" of the new reagent system to the predicate. Specific quantitative acceptance criteria are not explicitly detailed in the provided text in the form of numerical thresholds for accuracy, precision, or comparison studies. Instead, the performance section broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (ANALYETTE™ with Synermeds® 072 reagents) | "Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective." |
| Effective performance for the quantitative determination of various analytes in solution (serum, plasma, or urine). | The device is intended for the quantitative determination of a comprehensive list of analytes (Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol (includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lipase, Chloride). The statement of substantial equivalence implies effective performance. |
| Safety of the device. | "It was concluded from these results that this product is safe and effective." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "comparative studies" were conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a clinical chemistry analyzer, the ground truth is typically established by reference methods or highly accurate laboratory instruments rather than expert adjudication in the way it would be for image-based diagnostics.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable in the context of a clinical chemistry analyzer's performance evaluation as described. Ground truth is established through analytical measurements, not through human adjudication of diagnostic findings. Therefore, no adjudication method like 2+1 or 3+1 would be used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component, often comparing human readers with and without AI assistance. This device is a clinical chemistry analyzer, which provides quantitative measurements directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described for the ANALETTE™ clinical chemistry analyzer with MAS reagents is inherently a standalone performance in the context of the instrument measuring analyte concentrations. There is no "human-in-the-loop" performance component in the direct measurement by the analyzer. The comparison is between two reagent systems on the same analyzer, assessing the analytical performance.
7. The Type of Ground Truth Used
The ground truth for this type of device (a clinical chemistry analyzer) would typically be established by:
- Reference standard methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine clinical tests.
- Certified reference materials: Samples with known, validated concentrations of the analytes.
- Comparison to the predicate device: For a 510(k) submission seeking substantial equivalence, the performance of the new device (or reagent system) is directly compared to the legally marketed predicate device using patient samples and/or quality control materials. The predicate device's results serve as the pragmatic "ground truth" for demonstrating equivalence in a clinical setting.
The document implies the latter, stating "Substantially equivalence was established in comparative studies," meaning performance was compared against the predicate system.
8. The Sample Size for the Training Set
This information is not provided in the document. Clinical chemistry analyzers and their associated reagents are developed through analytical validation, which involves extensive testing, but the term "training set" is more commonly associated with machine learning algorithms. If there were any computational models or algorithms within the analyzer's software that required training (which is not explicitly indicated as relevant here beyond basic instrument calibration), the details of such a training set are absent.
9. How the Ground Truth for the Training Set Was Established
Since no "training set" in the machine learning sense is explicitly mentioned or detailed, and the focus is on analytical performance comparison (substantial equivalence), the method for establishing ground truth for a training set is not applicable or provided. The development of a clinical chemistry reagent kit involves rigorous analytical validation, where performance characteristics like accuracy, precision, linearity, and interference are established using known standards and patient samples, rather than a "ground truth for training" in the way an AI model would be trained.
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- G. Conclusions:
For the above reasons, we believe the ANALETTE™ clinical chemistry I of the acore reasons is analysis Systems Reagents to be substantially equivalent to the ANALETTE ™ clinical chemistry using Synermeds® 072 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 | ClassificationName: | Chemistry analyzer, micro | 862.2500 | |
|---|---|---|---|---|
| Manufacturer: | Precision Systems™, Inc. | Calcium | 862.1145 | |
| 16 Tech Circle | Creatinine | 862.1225 | ||
| Natick, MA. 01760 | Phosphorus | 862.1580 | ||
| Attention: Bill Haden | Albumin | 862.1035 | ||
| Medical Analysis Systems | Total Protein | 862.1635 | ||
| 5300 Adolfo Road | Glucose | 862.1345 | ||
| Camarillo, CA 93012 | Urea Nitrogen | 862.1770 | ||
| Proprietary Name: | ANALETTE ™ | Magnesium | 862.1495 | |
| Medical Analysis Systems Reagents | Creatine Kinase | 862.1215 | ||
| Calcium, | Alkaline Phosphatase | 862.1050 | ||
| Creatinine | Carbon Dioxide | 862.1160 | ||
| Phosphorus | Amylase | 862.1070 | ||
| Albumin | Cholesterol(includes HDL) | 862.1175 | ||
| Total Protein | Triglycerides | 862.1705 | ||
| Glucose | Total Bilirubin | 862.1110 | ||
| Urea Nitrogen | Direct Bilirubin | 862.1110 | ||
| Magnesium | Uric Acid | 862.1775 | ||
| Creatine Kinase | Lactate Dehydrogenase L | 862.1440 | ||
| Alkaline Phosphatase | Lactate Dehydrogenase P | 862.1440 | ||
| Carbon Dioxide | Alanine Aminotransferase | 862.1030 | ||
| Amylase | Aspartate Aminotransferase | 862.1100 | ||
| Cholesterol(includes HDL) | Gamma Glutamyl Transferase | 862.1360 | ||
| Triglycerides | Lipase | 862.1465 | ||
| Total Bilirubin | Chloride | 862.1170 | ||
| Direct Bilirubin | Intended Use: | An in vitro diagnostic automated clinical chemistryanalyzer for the analysis of analytes in solution. | ||
| Uric Acid | Predicate Device: | Precision Systems™, Inc, ANALETTE™ usingSynermeds® reagents | ||
| Lactate Dehydrogenase L | Performance: | Substantially equivalence was established incomparative studies.It was concluded from these results that this productis safe and effective. | ||
| Lactate Dehydrogenase P | Safe MedicalDevice Act 1990 | Precision Systems™ will make any additional safetyand effectiveness information for the ANALETTE ™Clinical Chemistry Analyzer available to interestedpersons upon request. | ||
| Alanine Aminotransferase | ||||
| Aspartate Aminotransferase | ||||
| Gamma Glutamyl Transferase | ||||
| Chloride |
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Lipase
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is composed of three curved lines that suggest movement and flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
Public Health Service
AUG 2 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Bill Haden VP Scientific and Regulatory Affairs Precision Systems Inc. 16 Tech Circle Natick, MA 01760
Re: K022072
Trade/Device Name: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX; CKA; CIT; CGS; CGA; CJY; CGX; CFJ; CJE; KHS; CIG; CEK; · JFJ; CGZ; JQB; CDQ; CHH; JGJ; JGY; CET; CEO; KNK Dated: June 14, 2002 Received: June 26, 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. Iisting 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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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "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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510k K022072 PRODUCT: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS 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, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, 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 and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.
R.Q. Hede
Bill Haden, Vice President June 12, 2002
Alberto Sarti for Jean
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
prescription use X
(for 21 CFR 801.109)
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.