(211 days)
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No
The document describes a standard automated clinical chemistry analyzer and does not mention any AI or ML components or capabilities.
No
The device is described as an "in vitro diagnostic automated clinical chemistry analyzer" intended for quantitative determination of analytes in solutions, such as serum, plasma, or urine. It is used for analysis, not treatment.
Yes
The "Device Description" explicitly states, "An in vitro diagnostic automated clinical chemistry analyzer." In vitro diagnostic devices are used for tests performed on samples taken from the human body, providing information for diagnostic purposes.
No
The device description explicitly states it is an "in vitro diagnostic automated clinical chemistry analyzer," which is a hardware device designed to perform chemical analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of analytes in solutions, such as serum, plasma, or urine." These are biological samples used for diagnostic purposes.
- Device Description: The device description clearly identifies it as an "in vitro diagnostic automated clinical chemistry analyzer."
- Predicate Device: The predicate device is also an "IR® 200," which is a clinical chemistry analyzer, further supporting its IVD nature.
The core function of analyzing biological samples to determine the presence and quantity of specific substances for diagnostic purposes is the defining characteristic of an IVD.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
JJF, CDQ, CEK, CEO, CFJ, CFM, CGA, CGS, CGX, CHG, CHH, CIG, CIT, CIX, CJE, CJY, CKA, JFJ, JGJ, JGY, JMO, JQB, KHS, KNK, LBR
Device Description
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 Circle
Natick, MA. 01760
Attention: Bill Haden |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | ANALETTE TM |
| Classification
Name: | 862.2500 |
| Intended Use: | An in vitro diagnostic automated clinical chemistry
analyzer for the analysis of analytes in solution. |
| Predicate Device: | Synermed IR® 200 manufactured by Precision
Systems TM, Inc, for Synermed® and as found in
Synermeds® 510(k) IR200 vs. the Hitachi® 705. |
| Performance: | Substantially equivalence was established in
comparative studies.
It was concluded from these results that this product
is safe and effective. |
| Safe Medical
Device Act 1990 Precision Systems TM will make any additional
safety and effectiveness information for the
ANALETTE TM Clinical Chemistry Analyzer
available to interested persons upon request. | |
1
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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Page 2
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)