(62 days)
Not Found
No
The description focuses on traditional analytical methods (photometry, potentiometry) and automation of manual procedures. There is no mention of AI, ML, or related concepts.
No.
The device is a chemistry analyzer used for diagnostic purposes (measuring analytes and electrolytes), not for treating or preventing diseases.
Yes
The AEROSET System is described as a "discrete photometric chemistry Analyzer for clinical use" and is intended to "measure a variety of analytes" and perform "electrolyte determinations." These functions are consistent with diagnostic devices used to analyze patient samples for diagnostic purposes.
No
The device description clearly states it is a "fully automated random access clinical chemistry Analyzer" and mentions hardware components like a spectrophotometer and an Ion-Selective Electrode module.
Yes, based on the provided information, the AEROSET System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Per 21 CFR, 682.2160, the AEROSET System is a discrete photometric chemistry Analyzer for clinical use." 21 CFR 682.2160 is a regulation specifically for Automated chemistry analyzers for clinical use, which are a type of IVD device.
- Function: The device is described as performing analytical procedures on samples (pipetting, heating, measuring color intensity, potentiometry for electrolytes) to measure various analytes. This is the core function of an IVD device – analyzing samples taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Clinical Use: The intended use clearly states "for clinical use," indicating it's used in a healthcare setting to aid in patient care.
Therefore, the description aligns perfectly with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Per 21 CFR, 682.2160, the AEROSET System 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, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The AEROSET System also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).
Product codes (comma separated list FDA assigned to the subject device)
JJE, JGS, CEM, CGZ
Device Description
The AEROSET System is a fully automated random access clinical chemistry Analyzer which utilizes spectrophotometry (mono and bichromatic modes of measurement). The AEROSET System has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, which can perform electrolyte determinations for sodium, potassium, and chloride. The AEROSET System can run up to 100 different assays simultaneously with a maximum throughput approaching 2000 tests per hour (depending on configuration).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
A correlation analysis between the AEROSET System and the Boehringer Mannheim Diagnostics' Hitachi 717 Chemistry Analyzer yielded the following results:
Total Protein: Correlation Coefficient 0.977, Slope 0.931, Y-axis intercept 0.105 g/dL
Alkaline Phosphatase: Correlation Coefficient 0.99, Slope 0.9, Y-axis intercept 3.4 U/L
Creatinine-Serum: Correlation Coefficient 0.995, Slope 0.924, Y-axis intercept -0.198 mg/dL
Creatinine-Urine: Correlation Coefficient 0.933, Slope 0.9743, Y-axis intercept 2.214 mg/dL
Urea Nitrogen: Correlation Coefficient 0.996, Slope 0.95, Y-axis intercept -1.114 mg/dL
Sodium-Serum: Correlation Coefficient 0.94, Slope 0.86, Y-axis intercept 16.14 mmol/L
Sodium-Urine: Correlation Coefficient 0.998, Slope 0.967, Y-axis intercept 1.227 mmol/L
Potassium-Serum: Correlation Coefficient 0.99, Slope 1.08, Y-axis intercept -0.49 mmol/L
Potassium-Urine: Correlation Coefficient 0.994, Slope 0.856, Y-axis intercept 2.273 mmol/L
Chloride-Serum: Correlation Coefficient 0.96, Slope 0.93, Y-axis intercept 3.9 mmol/L
Chloride-Urine: Correlation Coefficient 0.979, Slope 1.02, Y-axis intercept 5.38 mmol/L
The linearity test yielded the following results:
Total Protein: To 10.90 g/dL
Alkaline Phosphatase: To 1484.16 U/L
Creatinine-Serum: To 23.82 mg/dL
Creatinine-Urine: To 191.65 mg/dL
Urea Nitrogen: To 123.51 mg/dL
Sodium-Serum: To 182.92 mmol/L
Sodium-Urine: To 398.02 mmol/L
Potassium-Serum: To 8.74 mmol/L
Potassium-Urine: To 400.24 mmol/L
Chloride-Serum: To 148.88 mmol/L
Chloride-Urine: To 411.00 mmol/L
The precision of the representative assays was acceptable for both normal and abnormal controls. The total %CV's for both the normal and abnormal controls ranged from 1.0 to 5.3 and 0.7 to 4.0 respectively.
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.
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.
Not Found
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).
Not Found
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.
0
KA80367
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺮﺍﺟﻊ
APR - 1 1998
Section III
510(k) Summary
AEROSET™ System 510(k)
January 27, 1998
1:25 PM Final
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510(k) Summary
Submitter's name/address
Abbott Laboratories 1920 Hurd Drive M.S. 1-8 Irving, Texas 75038 Contact Person Andrew Johnson Section Manager Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
Date of Preparation of this Summary: Device Trade or Proprietary Name: Device Common Name: Classification Number/Class:
January 27, 1998 AEROSET™ System Clinical Chemistry Analyzer Classification Number 75JJD, Class I 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: _______________________________________________________________________________________________________________________________________________
Description:
The following is a brief description of the AEROSET System.
The AEROSET System is a fully automated random access clinical chemistry Analyzer which utilizes spectrophotometry (mono and bichromatic modes of measurement). The AEROSET System has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, which can perform electrolyte determinations for sodium, potassium, and chloride. The AEROSET System can run up to 100 different assays simultaneously with a maximum throughput approaching 2000 tests per hour (depending on configuration).
AEROSET™ System 510(k) January 27, 1998 1:25 PM Final
2
Substantial Equivalence:
Substantial equivalence has been demonstrated between the AEROSET System and the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer (K872494).
Both systems utilize monochromatic and bichromatic spectrophotometry to perform quantitative kinetic and endpoint clinical chemistries. Both Analyzers perform quantitative analysis of sodium, potassium, and chloride in clinical samples. Both Analyzers have an Ion-Selective Electrode module, the AEROSET is a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT).
Intended Use:
The AEROSET System is a fully automated, random access, clinical chemistry Analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations. The system also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).
Performance Characteristics:
A correlation analysis between the AEROSET System and the Boehringer Mannheim Diagnostics' Hitachi 717 Chemistry Analyzer yielded the following results:
| Representative | Correlation | Slope | Y-axis intercept |
|---|---|---|---|
| Method | Coefficient | ||
| Total Protein | 0.977 | 0.931 | 0.105 g/dL |
| Alkaline | 0.99 | 0.9 | 3.4 U/L |
| Phosphatase | |||
| Creatinine-Serum | 0.995 | 0.924 | -0.198 mg/dL |
| Creatinine-Urine | 0.933 | 0.9743 | 2.214 mg/dL |
| Urea Nitrogen | 0.996 | 0.95 | -1.114 mg/dL |
| Sodium-Serum | 0.94 | 0.86 | 16.14 mmol/L |
| Sodium-Urine | 0.998 | 0.967 | 1.227 mmol/L |
| Potassium-Serum | 0.99 | 1.08 | -0.49 mmol/L |
| Potassium-Urine | 0.994 | 0.856 | 2.273 mmol/L |
| Chloride-Serum | 0.96 | 0.93 | 3.9 mmol/L |
| Chloride-Urine | 0.979 | 1.02 | 5.38 mmol/L |
3
The linearity test yielded the following results:
| Representative Method | Linearity |
|---|---|
| Total Protein | To 10.90 g/dL |
| Alkaline Phosphatase | To 1484.16 U/L |
| Creatinine-Serum | To 23.82 mg/dL |
| Creatinine-Urine | To 191.65 mg/dL |
| Urea Nitrogen | To 123.51 mg/dL |
| Sodium-Serum | To 182.92 mmol/L |
| Sodium-Urine | To 398.02 mmol/L |
| Potassium-Serum | To 8.74 mmol/L |
| Potassium-Urine | To 400.24 mmol/L |
| Chloride-Serum | To 148.88 mmol/L |
| Chloride-Urine | To 411.00 mmol/L |
The precision of the representative assays was acceptable for both normal and abnormal controls. The total %CV's for both the normal and abnormal controls ranged from 1.0 to 5.3 and 0.7 to 4.0 respectively.
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Conclusion:
The data demonstrates that the AEROSET System and the Boehringer Mannheim
Diagnostics' Hitachi 717 Chemistry Analyzer are substantially equivalent.
AEROSET™ System 510(k) January 27, 1998 1:25 PM Final
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the head and face visible.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 1 1998
Andrew Johnson Section Manager, Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K980367 Re: AEROSET™ System Regulatory Class: II Product Code: JJE, JGS, CEM, CGZ Dated: January 27, 1998 Received: January 29, 1998
Dear Mr. Johnson:
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 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 The general controls provisions of the Act 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 Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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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 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/dsmamain.html".
sincerely yours,
Steven Bitman
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):
Device Name:
Indications For Use:
- Per 21 CFR, 682.2160, the AEROSET System 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, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The AEROSET System also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980367
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
500(x) Number saivs 1 101810068 I leading to noisivil (HO-ugis uoisiniQ)
AEROSETTM System 510 (k) January 27, 1998 1:25 PM Final