(211 days)
The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, 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 Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
The provided text is a 510(k) premarket notification summary and the FDA's response letter for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER. It establishes "substantial equivalence" to a predicate device, the Synermed IR® 200.
However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The "Performance" section within the Summary of Safety and Effectiveness only states: "Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective." This is a general statement, not a detailed report of performance against quantitative criteria.
The information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is typically found in the full 510(k) submission, not in this public summary document. The summary only attests that such studies were performed and deemed sufficient to show substantial equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document only states that "Substantially equivalence was established in comparative studies," implying that the device's performance was comparable to the predicate device, Synermed IR® 200, across various analytes. Specific quantitative criteria and performance values are not detailed. | Not specified in the provided document. The document does not provide specific metrics like accuracy, precision, sensitivity, or specificity. It only states that the device was found to be "safe and effective" and "substantially equivalent" to the predicate. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified in the provided document. It refers generally to "comparative studies" but provides no details on their design or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This device is an automated clinical chemistry analyzer. The "ground truth" for chemical measurements would typically be established through reference methods or certified standards, not expert reader consensus. The document does not mention experts establishing a ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations (e.g., image reading), not for automated chemical analyzers where results are quantitative.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device is a standalone automated clinical chemistry analyzer, not an AI-assisted diagnostic tool for human readers. Such a study would not be relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The ANALETTE™ is described as an "automated clinical chemistry analyzer for the analysis of analytes in solution." Its performance is inherently standalone for quantitative measurements. The "comparative studies" mentioned would have evaluated its direct measurements against a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Reference Methods/Standards: For an automated clinical chemistry analyzer, the ground truth would typically be established by validated reference methods, certified reference materials, or comparison to results from highly accurate lab instruments. The document does not explicitly state the method, but this is the standard for such devices.
8. The sample size for the training set
- Not applicable/Not specified. This device is a traditional automated chemistry analyzer, not an AI/ML device that requires a "training set" in the machine learning sense. Its operation is based on established chemical principles and pre-programmed algorithms for measurement and calculation.
9. How the ground truth for the training set was established
- Not applicable. As noted above, this is not an AI/ML device that uses a "training set."
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JUN 5 2002
PRECISION SYSTEMS INC
16 Tech Circle Natick MA USA
Phone 1 508 655 7010 E-mail: precisionsystems@msn.com
Fax 1 508 653 6999
Summary of Safety and Effectiveness: July 2, 2001
| Manufacturer: | Precision Systems TM, Inc.16 Tech CircleNatick, MA. 01760Attention: Bill Haden |
|---|---|
| Proprietary Name: | ANALETTE TM |
| ClassificationName: | 862.2500 |
| Intended Use: | An in vitro diagnostic automated clinical chemistryanalyzer for the analysis of analytes in solution. |
| Predicate Device: | Synermed IR® 200 manufactured by PrecisionSystems TM, Inc, for Synermed® and as found inSynermeds® 510(k) IR200 vs. the Hitachi® 705. |
| Performance: | Substantially equivalence was established incomparative studies.It was concluded from these results that this productis safe and effective. |
| Safe MedicalDevice Act 1990 Precision Systems TM will make any additionalsafety and effectiveness information for theANALETTE TM Clinical Chemistry Analyzeravailable to interested persons upon request. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5 2002 "JUN
Mr. Bill Haden VP Scientific and Regulatory Affairs Precision Systems Inc. 16 Tech Circle Natick, MA 01760
K013654 Re:
Trade/Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test Regulatory Class: Class II; Product Code: JJF, CDQ, CEK, CEO, CFJ, CFM, CGA, CGS, CGX, CHG, CHH, CIG,CIT, CIX, CJE, CJE, CJY, CKA, JFJ, JGJ, JGY, JMO, JQB, KHS,KNK, LBR Dated: April 8, 2002 Received: April 8, 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 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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 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/cdrh/dsma/dsmamain.html
Sincerely yours.
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K013654
Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
Indications For Use:
The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, 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 Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013654
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.