(20 days)
The ALCYON Analyzer is an automated chemistry analyzer for in vitro diagnostic use. The analyzer performs quantitative kinetic and endpoint determinations of specific analytes. The ALCYON 300i Analyzer with the ISE Module additionally measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples, using indirect potentiometry.
Per 21 CFR, 682.2160, the ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing 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. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
The ALCYON Analyzer is an automated open system for quantitative analysis of clinical chemistries. The ALCYON Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abbott ALCYON Analyzer:
Acceptance Criteria and Device Performance Study for Abbott ALCYON Analyzer
1. Table of Acceptance Criteria and Reported Device Performance
| Analyte | Substance | Acceptance Criteria (Difference from Serum Baseline) | Reported Device Performance (Mean % Recovery) | Meets Criteria? |
|---|---|---|---|---|
| Sodium | SST | < ± 10% | 99.7 % | Yes |
| Na Hep (full draw) | < ± 10% | 100.7 % | Yes | |
| Li Hep | < ± 10% | 99.6 % | Yes | |
| NH4 Hep | < ± 10% | 99.9 % | Yes | |
| KEDTA | < ± 10% | 95.0 % | Yes | |
| Na Citrate | < ± 10% | 188.5 % | No | |
| Plastic | < ± 10% | 99.8 % | Yes | |
| Na Hep (1/2 draw) | < ± 10% | 100.3 % | Yes | |
| Potassium | SST | < ± 10% | 99.9 % | Yes |
| Na Hep (full draw) | < ± 10% | 91.0 % | Yes | |
| Li Hep | < ± 10% | 92.3 % | Yes | |
| NH4 Hep | < ± 10% | 91.2 % | Yes | |
| KEDTA | < ± 10% | 759.5 % | No | |
| Na Citrate | < ± 10% | 76.7 % | No | |
| Plastic | < ± 10% | 100.8 % | Yes | |
| Na Hep (1/2 draw) | < ± 10% | 92.1 % | Yes | |
| Chloride | SST | < ± 10% | 99.7 % | Yes |
| Na Hep (full draw) | < ± 10% | 100.0 % | Yes | |
| Li Hep | < ± 10% | 99.8 % | Yes | |
| NH4 Hep | < ± 10% | 99.6 % | Yes | |
| KEDTA | < ± 10% | 99.5 % | Yes | |
| Na Citrate | < ± 10% | 103.4 % | Yes | |
| Plastic | < ± 10% | 100.1 % | Yes | |
| Na Hep (1/2 draw) | < ± 10% | 99.9 % | Yes |
Note: The acceptance criteria were for "Less than ± 10% difference from the serum specimen collection tube baseline." The "Mean % Recovery" values represent the performance relative to this baseline. Values outside 90%-110% (i.e., <90% or >110%) indicate failure to meet the criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the number of individual samples or patients used in the anticoagulant studies. It lists various anticoagulant types and collection tubes (e.g., SST, Na Hep, Li Hep, NH4 Hep, KEDTA, Na Citrate, Plastic) and "full draw" vs "1/2 draw" for Sodium Heparin.
- Data Provenance: The document does not specify the country of origin of the data, nor does it explicitly state if the study was retrospective or prospective. Given the nature of performance characteristic studies for device clearance, it is most likely a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This study evaluates the performance of the analyzer with different anticoagulant types against a serum baseline. It does not involve expert interpretation or ground truth established by experts in the same way an imaging or diagnostic AI study would. The ground truth is the chemical measurement from serum specimens.
4. Adjudication Method for the Test Set
- Not applicable, as this is a chemical analytical performance study, not an interpretative study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not performed. This study focuses on the analytical performance of the device with different sample types, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this study is a standalone performance evaluation of the ALCYON Analyzer's ISE module. It assesses the device's ability to accurately measure electrolytes in different sample types, independent of human interaction beyond operating the machine and preparing samples.
7. The Type of Ground Truth Used
- The ground truth used was analytical measurement from serum specimens. The performance of other specimen types (plasma with various anticoagulants) was compared against the results obtained from serum specimens, which served as the reference standard.
8. The Sample Size for the Training Set
- The document does not mention a "training set" in the context of an AI/algorithm. This device is an analyzer for quantitative chemical analysis, not an AI or machine learning algorithm that requires a training set in the typical sense. Its operational parameters and calibration are established through standard chemical and engineering principles rather than machine learning on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no explicitly defined "training set" for an AI/ML algorithm. The calibration and operational parameters of such a device are established during its design and manufacturing through standard chemical and engineering validation processes, referencing known chemical properties and standards.
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510(k) Summary
OCT 5 1999
| Submitter's name/address | Contact Person |
|---|---|
| Abbott Laboratories | Mark Littlefield |
| 1920 Hurd Drive | Section Manager |
| M.S. 1-8 | Regulatory Affairs |
| Irving, Texas 75038 | (972) 518-6062 |
| Fax (972) 753-3367 | |
| Date of Preparation of this Summary: | September 13, 1999 |
| Device Trade or Proprietary Name: | Abbott ALCYON Analyzer |
| Device Common Name: | Clinical Chemistry Analyzer (withoptional ISE Module) |
| Classification Numbers/Class: | 75JJD, Class 1 |
| 75JGS, Class II | |
| 75CEM, Class II | |
| 75CGZ, Class II |
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K993083
Description:
The ALCYON Analyzer is an automated open system for quantitative analysis of clinical chemistries. The ALCYON Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
Substantial Equivalence:
Substantial equivalence has been demonstrated between the use of serum specimens and plasma specimens for the quantitative determination of sodium, and chloride using indirect potentiometry (ISE module) on the ALCYON 300i Analyzer.
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Intended Use:
The ALCYON Analyzer is an automated chemistry analyzer for in vitro diagnostic use. The analyzer performs quantitative kinetic and endpoint determinations of specific analytes. The ALCYON 300i Analyzer with the ISE Module additionally measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples, using indirect potentiometry.
STATE AND ATTERNAL PROPERTY COLLECTION COLLECTION CONTROLLERS OF CONSULTION OF CONSULTION OF
Performance Characteristics:
Anticoagulant studies were performed using Lithium Heparin, Sodium Heparin, Ammonia Heparin, Sodium Citrate, Potassium-EDTA, plastic tubes and baselined against serum specimen tubes.
Less than ± 10% difference from the serum specimen collection tube baseline was observed for sodium heparin, lithium heparin, ammonium heparin, plastic, and SST collection tubes for the quantitation of sodium, potassium, and chloride.
Sodium Anticoagulant Recovery
| Substance | Mean of% Recovery |
|---|---|
| SST | 99.7 |
| Na Hep (full draw) | 100.7 |
| Li Hep | 99.6 |
| NH4 Hep | 99.9 |
| KEDTA | 95.0 |
| Na Citrate | 188.5 |
| Plastic | 99.8 |
| Na Hep (1 / 2 draw) | 100.3 |
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Potassium Anticoagulant Recovery
| S u b s t a n c e | M e a n o f% R e c o v e r y |
|---|---|
| S S T | 9 9 . 9 |
| N a H e p ( f u l l d r a w ) | 9 1 . 0 |
| L i H e p | 9 2 . 3 |
| N H 4 H e p | 9 1 . 2 |
| K E D T A | 7 5 9 . 5 |
| N a C i t r a t e | 7 6 . 7 |
| P l a s t i c | 1 0 0 . 8 |
| N a H e p ( 1 / 2 d r a w ) | 9 2 . 1 |
Chloride Anticoagulant Recovery
| S u b s t a n c e | M e a n o f | |||
|---|---|---|---|---|
| % R e c o v e r y | ||||
| S S T | 9 9 . 7 | |||
| N a H e p ( f u l l d r a w ) | 1 0 0 . 0 | |||
| L i H e p | 9 9 . 8 | |||
| N H 4 H e p | 9 9 . 6 | |||
| K E D T A | 9 9 . 5 | |||
| N a C i t r a t e | 1 0 3 . 4 | |||
| P l a s t i c | 1 0 0 . 1 | |||
| N a H e p ( 1 / 2 d r a w ) | 9 9 . 9 |
Conclusion:
The data demonstrates that the use of plasma specimens is an acceptable specimen type for the quantitative determinations of sodium, potassium, and chloride using indirect potentiometry on the ALCYON 300i Analyzer.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 5 1999
Mr. Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories ADD Regulatory Affairs 1920 Hurd Drive Irving, Texas 75038
Re: K993083
Trade Name: ALCYON™ 300I (with ISE Module) Analyzer Regulatory Class: II Product Code: CEM, CGZ, JGS Dated: September 15, 1999 Received: September 15, 1999
Dear Mr. Littlefield:
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 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). 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 (Premarket Approval), 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 895. 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.
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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 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"(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,
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
Enclosure
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510(k) Number (if known): 5993083
ALCYON™ Analyzer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
જુદી -Per 21 CFR, 682.2160, the ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing 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. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
Jancooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993083
(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)
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.