(57 days)
The Elecsys 2010 analyzer is intended to be used for the in vitro quantitative and qualitative analysis of analytes in body fluids.
The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro. The formation of qualitative determination of analytes in human serum and plasm
The Elecsys 2010 analyzer is a fully automated, random access, computer controlled analytical system for quantitative and qualitative determinations of analytes in body fluids
The Elecsys 2010 Analyzer is intended for in vitro quantitative and qualitative analysis of analytes in body fluids. The study compared the Elecsys 2010 Analyzer to the predicate device, the ES300 Immunoassay system, to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria (Implied by equivalence to predicate) and Reported Device Performance:
The acceptance criteria for the Elecsys 2010 Analyzer are implicitly defined by its equivalence to the predicate ES300 Analyzer's performance. The study demonstrates this equivalence through method comparison data using least squares regression. The reported device performance is presented as the regression equations, the standard error of the estimate (SEE), and the correlation coefficient (r) for various analytes.
| Feature | Acceptance Criteria (Implied by equivalence to ES300) | Reported Device Performance (Elecsys 2010 vs. ES300) |
|---|---|---|
| Method ComparisonT4 | Substantial equivalence to ES300 | Y = 1.02x + 0.85SEE = 5.39r = 0.947 |
| Method ComparisonFT4 | Substantial equivalence to ES300 | Y = 0.954X + 0.18SEE = 1.11r = 0.981 |
| Method ComparisonTSH | Substantial equivalence to ES300 | Y = 1.09X + 0.14SEE = 0.798r = 0.991; n = 132 |
| Method ComparisonT-Uptake | Substantial equivalence to ES300 | Y = 0.99X - 0.03SEE = 0.04r = 0.908; n = 319 |
| Method ComparisonhCG | Substantial equivalence to ES300 | Y = 1.35X - 9.21SEE = 17.50r = 0.989; n = 64 |
| Method ComparisonTroponin-T | Substantial equivalence to ES300 | Y = -0.033 + 0.996SEE = 0.547r = 0.969; n = 54 |
2. Sample Size Used for the Test Set and the Data Provenance:
The sample sizes for the method comparison test sets are as follows:
- TSH: n = 132
- T-Uptake: n = 319
- hCG: n = 64
- Troponin-T: n = 54
- T4 and FT4: Sample sizes are not explicitly stated within the provided text.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is generally not applicable to immunoassay analyzer performance studies. The "ground truth" for method comparison studies like this is typically the measurements obtained from the predicate device (ES300 Analyzer), which is itself a legally marketed and presumably validated device. There are no "experts" establishing a subjective ground truth in this context.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this study evaluates the equivalence of quantitative measurements between two instruments. There is no subjective assessment requiring adjudication.
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:
This information is not applicable. The Elecsys 2010 Analyzer is an automated immunoassay analyzer, not an AI-assisted diagnostic imaging or analysis tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance study conducted for the Elecsys 2010 Analyzer is inherently a standalone performance evaluation. It assesses the analytical capability of the instrument itself in comparison to another automated instrument (the predicate ES300 analyzer). There is no "human-in-the-loop" component in the performance data presented.
7. The Type of Ground Truth Used:
The "ground truth" used in this study is the analytical results obtained from the predicate device, the Boehringer Mannheim ES300 Immunoassay system. This is a form of comparative measurement; the performance of the new device is benchmarked against an established and legally marketed device.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Immunoassay analyzers are typically developed and validated through analytical studies, not through AI/machine learning training sets in the traditional sense. The phrase "training set" is usually associated with machine learning model development, which is not the primary methodology for validating a device like the Elecsys 2010 Analyzer.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The development and validation of the Elecsys 2010 Analyzer would have involved rigorous analytical studies to establish its precision, accuracy, linearity, and other performance characteristics, often against reference methods or established standards, rather than a labeled training dataset for an AI model.
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JUN 1 4 1996
ਸਿੰਘ ਸੀ।
ਹਵਾਲੇ
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2327 |
| Contact Person: John D. Stevens | |
| Date Prepared: April 17, 1996 | |
| 2) Device name | Proprietary name: Elecsys 2010 ® analyzer |
| Common name: immunoassay analyzer | |
| Classification name: Discrete photometric analyzer for clinical use | |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim ES300 Immunoassay system. |
| 4) Device Description | The Elecsys 2010 analyzer is a fully automated, random access, computer controlled analytical system for quantitative and qualitative determinations of analytes in body fluids |
| 5) Intended use | The Elecsys 2010 analyzer is intended to be used for the in vitro quantitative and qualitative analysis of analytes in body fluids. |
| Continued on next page |
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510(k) Summary Elecsys® 2010 Analyzer, Continued
- Comparison to predicate 'device
The Boehringer Mannheim Elecsys 2010 analyzer is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed ES300 Immunoassay analyzer.
The following table compares the Elecsys 2010 with the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
| Feature | Elecsys 2010 Analyzer | ES300 Analyzer |
|---|---|---|
| Intended use | Intended for the in vitroquantitative/qualitativedetermination of analytes inbody fluids | Same |
| Number ofreagents | Up to 2 | Same |
| Sampledetection | Liquid level detection andclot detection | Same |
| Sample type | Serum and plasma | Same |
| Host interface | RS232C bidirectional | Same |
Differences:
| Feature | Elecsys 2010 analyzer | ES300 analyzer |
|---|---|---|
| Operatingprinciple | Electrochemiluminescenceimmunoassay method type | Enzyme-linkedimmunosorbent assay methodtype |
| Detectionsystem | Flow throughelectrochemiluminescencedetection cell | Flow through cuvette withhalogen lamp light source |
| Samplepositions | 30 positions for samples,controls and calibrators | 150 positions for samples,controls and calibrators |
| Samplevolume / test | 10 to 50μL | 5 to 200 μL |
| Reagentpositions | 15 reagent positions2 diluent/reagent positions1 BlankCell position | 12 reagent positions1 cleaning solution2 universal substrate |
Continued on next page
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510(k) Summary, Elecsys 2010® Analyzer Continued
- Comparison to predicate device, (cont.)
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Performance Characteristics:
| Feature | Elecsys 2010 vs. ES300Least Squares Regression |
|---|---|
| MethodComparisonT4 | $Y = 1.02x +0.85$$SEE = 5.39$$r = 0.947$ |
| MethodComparisonFT4 | $Y = 0.954X + 0.18$$SEE = 1.11$$r = 0.981$ |
| MethodComparisonTSH | $Y = 1.09X + 0.14$$SEE = 0.798$$r = 0.991; n = 132$ |
| MethodComparisonT-Uptake | $Y = 0.99X - 0.03$$SEE = 0.04$$r = 0.908; n = 319$ |
| MethodComparisonhCG | $Y = 1.35X - 9.21$$SEE = 17.50$$r = 0.989; n = 64$ |
| MethodComparisonTroponin-T | $Y = - 0.033 + 0.996$$SEE = 0.547$$r = 0.969; n = 54$ |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 7 2000
Ms. Kay Taylor Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K961481 Trade Name: Elecsys 2010 Analyzer Regulatory Class: II Product Code: CDX, CEC, DHA, JJE, JLW, KHQ, MMI Dated: May 29, 1996 Received: May 30, 1996
Dear Ms. Taylor:
This letter corrects our substantially equivalent letter of June 14, 1996, regarding the Elecsys 2010 Analyzer. The Elecsys 2010, associated reagents, and subsequent models within the Elecsys Family of analyzers referenced in K961481 were only classified as a class I device. Elecsys analyzers with their associated reagents are considered combination devices and carry the highest classification as stated in Blue Book memo #K86-3 "When such a device is found to be SE, it combines devices from different classes and is classified in the highest of the predicate device classifications."
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use ato t and re 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 prior to they 20, 1978, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act). You may, therefore, market the device, subject to the general controls Cosmone Act. The Act. The general controls provisions of the Act include requirements for annual provision, 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 If your device is elassifited to such additional controls. Existing major regulations (1 centurior reproval) in the Code of Federal Regulations, Title 21, Parts 800 to 895.
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A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 noulicate 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, (302) 59 mtet the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Kim Zofia
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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510(k) Number (if known): V961481
Device Name: Elecsys® 2010 Analyzer
Indications for Use:
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The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro.
The formation of qualitative determination of analytes in human serum and plasm The Elecsys 2010 analyzer is an immunoassay analyzer intended for the II. The II. The Street
C. Robhs
(Division Sign-Off) Division of Clinical Laboratory I 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric 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. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.