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).

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).

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a correlation study comparing the AEROSET™ System to a legally marketed predicate device, the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer. The acceptance criteria are implicitly based on demonstrating "substantial equivalence," which is shown through high correlation coefficients, and slopes close to 1, and small Y-axis intercepts. Linearity and acceptable precision are also shown.

Because this is a substantial equivalence submission, specific quantitative acceptance criteria (e.g., "correlation coefficient must be >0.95") are not explicitly stated as they would be for a de novo submission. Instead, the performance is presented to demonstrate that it is comparable to the predicate.

Performance Metric	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (AEROSET™ System vs. Hitachi 717)
Correlation	High correlation coefficient (close to 1.0)	Total Protein: 0.977Alkaline Phosphatase: 0.99Creatinine-Serum: 0.995Creatinine-Urine: 0.933Urea Nitrogen: 0.996Sodium-Serum: 0.94Sodium-Urine: 0.998Potassium-Serum: 0.99Potassium-Urine: 0.994Chloride-Serum: 0.96Chloride-Urine: 0.979
Slope	Close to 1.0	Total Protein: 0.931Alkaline Phosphatase: 0.9Creatinine-Serum: 0.924Creatinine-Urine: 0.9743Urea Nitrogen: 0.95Sodium-Serum: 0.86Sodium-Urine: 0.967Potassium-Serum: 1.08Potassium-Urine: 0.856Chloride-Serum: 0.93Chloride-Urine: 1.02
Y-axis intercept	Close to 0	Total Protein: 0.105 g/dLAlkaline Phosphatase: 3.4 U/LCreatinine-Serum: -0.198 mg/dLCreatinine-Urine: 2.214 mg/dLUrea Nitrogen: -1.114 mg/dLSodium-Serum: 16.14 mmol/LSodium-Urine: 1.227 mmol/LPotassium-Serum: -0.49 mmol/LPotassium-Urine: 2.273 mmol/LChloride-Serum: 3.9 mmol/LChloride-Urine: 5.38 mmol/L

Linearity:

Performance Metric	Acceptance Criteria (Implicit for Acceptable Analytical Range)	Reported Device Performance (AEROSET™ System)
Linearity	Demonstrated across a clinically relevant range	Total Protein: To 10.90 g/dLAlkaline Phosphatase: To 1484.16 U/LCreatinine-Serum: To 23.82 mg/dLCreatinine-Urine: To 191.65 mg/dLUrea Nitrogen: To 123.51 mg/dLSodium-Serum: To 182.92 mmol/LSodium-Urine: To 398.02 mmol/LPotassium-Serum: To 8.74 mmol/LPotassium-Urine: To 400.24 mmol/LChloride-Serum: To 148.88 mmol/LChloride-Urine: To 411.00 mmol/L

Precision:

Performance Metric	Acceptance Criteria (Implicit for Acceptable Analytical Reproducibility)	Reported Device Performance (AEROSET™ System)
Total %CV	Acceptable (typically within industry standards for clinical chemistry)	Normal controls: 1.0 to 5.3Abnormal controls: 0.7 to 4.0 (acceptable)

2. Sample Size and Data Provenance:

Sample Size: The document does not specify the exact sample size (number of patient samples) used for the correlation analysis, linearity, or precision studies. It only lists the analytes tested.
Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications:

Number of Experts: Not applicable. This study involves the performance of a clinical chemistry analyzer, not a diagnostic imaging or classification task requiring expert interpretation. The "ground truth" (or reference method) in this context is the performance of the predicate device (Hitachi 717) and established analytical standards for linearity and precision.
Qualifications of Experts: Not applicable for this type of analytical device validation.

4. Adjudication Method:

Adjudication Method: Not applicable. This study compares quantitative analytical measurements between two instruments. There is no subjective human interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. The AEROSET System is a standalone clinical chemistry analyzer, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only):

Standalone Study: Yes, the entire performance study (correlation, linearity, precision) represents the standalone performance of the AEROSET™ System. Clinical chemistry analyzers are inherently "standalone" in this context, meaning their performance is evaluated independently of human interpretation in a diagnostic workflow. The "algorithm" here is the underlying analytical methods and hardware of the device. The reported performance metrics directly reflect what the device itself measures.

7. Type of Ground Truth Used:

Type of Ground Truth:
- For Correlation: The "ground truth" or reference method for the correlation analysis was the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer. The AEROSET™ System's results were compared against this predicate device's results.
- For Linearity: The ground truth for linearity is established through analytical standards of known concentrations, which are measured by the device to determine if its response is proportional to the analyte concentration across the specified range.
- For Precision: The ground truth for precision is established by running control materials (normal and abnormal) multiple times to assess the reproducibility of the measurements.

8. Sample Size for the Training Set:

Sample Size: Not applicable. The AEROSET™ System is a traditional clinical chemistry analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its operational parameters and performance characteristics are determined by its physical design, chemical reagents, and established analytical principles, not by learning from a dataset.

9. How Ground Truth for Training Set Was Established:

Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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KA80367

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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.

AEROSET™ System 510(k) January 27, 1998 1:25 PM Final

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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

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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.

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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Page 2

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)

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

Regulation Number and Section

§ 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.