The Bayer Immuno 1™ System has been upgraded for Laboratory Automation capability. Software and Hardware will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation System (LAS) will coordinate the scheduling, sample identification, and physical transfer of samples, as demonstrated for the following representative methods: CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake.

Device Description

Bayer Immuno 1" System Upgraded for Laboratory Automation Capability

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document is a 510(k) summary for an upgrade to the Bayer Immuno 1™ System. The primary goal of the submission is to demonstrate substantial equivalence to the predicate device (the original Bayer Immuno 1™ System). Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate device. The study aims to show that the "Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability" (the upgraded device) performs comparably to the "Bayer Immuno 1™ System" (the predicate device).

The document presents two key performance metrics for eight representative assays: Precision (Total CV %) and Correlation (Correlation Coefficient 'r' and Standard Error 'Sy.x') between the upgraded and predicate systems.

Method	Performance Metric	Acceptance Criteria (Predicate Device)	Reported Device Performance (Upgraded System)	Comparison / Implied Acceptance
Precision (Total CV %)
CEA	Total CV	2.3% - 1.8%	3.3% - 1.2%	The CVs for the upgraded system are largely comparable to, and in some cases better (e.g., 1.2% vs 2.2% at 13.29 ng/mL), or slightly higher (3.3% vs 2.3% at 1.54 ng/mL) than the predicate. The exact acceptance threshold for differences in CV isn't explicitly stated, but the values suggest a similar level of precision.
FSH	Total CV	3.2% - 2.8%	1.6% - 0.7%	Upgraded system shows consistently lower (better) CVs than the predicate device.
Free T4	Total CV	15.4% - 3.1%	4.1% - 4.7%	Upgraded system shows significantly better CVs at lower concentrations (4.1% vs 15.4%) and comparable or slightly higher at higher concentrations.
PSA	Total CV	0.007% - 3.4%	3.1% - 2.4%	The range of concentrations and corresponding CVs don't perfectly align, but the upgraded system's CVs generally fall within a similar low percentage range, indicating comparable precision.
T3	Total CV	13.3% - 3.9%	5.1% - 2.0%	Upgraded system shows consistently lower (better) CVs, especially at lower concentrations (5.1% vs 13.3%).
T4	Total CV	3.6% - 2.5%	1.6% - 1.2%	Upgraded system shows consistently lower (better) CVs.
TSH	Total CV	13.0% - 1.8%	6.4% - 1.2%	Upgraded system shows lower (better) CVs, particularly at lower concentrations (6.4% vs 13.0%).
T-Uptake	Total CV	2.8% - 2.4%	3.3% - 2.2%	Generally comparable, with some values slightly higher or lower than the predicate.
Correlation
CEA	Correlation Coeff 'r'	N/A (implicit target >0.98)	0.998	Excellent correlation, indicating substantial equivalence.
	Standard Error 'Sy.x'	N/A	0.116	Low standard error, indicating good agreement.
FSH	Correlation Coeff 'r'	N/A	0.999	Excellent correlation.
	Standard Error 'Sy.x'	N/A	0.841	Low standard error.
Free T4	Correlation Coeff 'r'	N/A	0.988	Good correlation.
	Standard Error 'Sy.x'	N/A	0.042	Low standard error.
PSA	Correlation Coeff 'r'	N/A	1.000	Excellent correlation.
	Standard Error 'Sy.x'	N/A	0.066	Low standard error.
T3	Correlation Coeff 'r'	N/A	0.987	Good correlation.
	Standard Error 'Sy.x'	N/A	0.046	Low standard error.
T4	Correlation Coeff 'r'	N/A	0.997	Excellent correlation.
	Standard Error 'Sy.x'	N/A	0.141	Low standard error.
TSH	Correlation Coeff 'r'	N/A	1.000	Excellent correlation.
	Standard Error 'Sy.x'	N/A	0.108	Low standard error.
T-Uptake	Correlation Coeff 'r'	N/A	0.991	Excellent correlation.
	Standard Error 'Sy.x'	N/A	0.019	Low standard error.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- CEA, FSH, T3, TSH: 360 samples each
- Free T4: 355 samples
- PSA: 200 samples
- T4: 356 samples
- T-Uptake: 358 samples
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA (USA), it's highly probable the testing was conducted in the US, but this is not confirmed. The nature of precision and correlation studies for in vitro diagnostics usually involves prospective testing of prepared samples and patient samples.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This type of study does not involve "experts" in the sense of clinical reviewers establishing a diagnostic "ground truth." Instead, the "ground truth" for the test set is established by the measurements from the predicate device itself. The comparison is between the assay results from the upgraded device and the predicate device. Therefore, this question is not directly applicable to this type of performance study.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method used as the study compares the quantitative output of one instrument against another, not diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases. It's an in vitro diagnostic device for automated laboratory testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.

Yes, the performance data presented is for the device's standalone performance. The "upgraded system" operates automatically within the laboratory automation context. The data in Attachment 3 shows the precision and correlation of the upgraded automated system compared to the predicate automated system.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) is the measurements obtained from the Bayer Immuno 1™ System (the predicate device). The study's purpose is to demonstrate that the upgraded system provides results that are substantially equivalent to those produced by the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a distinct "training set" in the conventional sense. The device's operation is based on established immuno-assay principles and factory calibration, not on learning from a large dataset. The data presented demonstrates the analytical performance of the system.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of this device's technology. The calibration and control procedures for such a device would typically follow standard laboratory quality control protocols using certified reference materials or established control samples.

Summary

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Attachment 3

7 1998 DEC

Summary of Safety and Effectiveness

Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability

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. Below is a comparison of performance, using eight representative assays, between the Bayer Immuno 1 System upgraded for Laboratory Automation capability and the Bayer Immuno 1™ System, already granted clearance of substantial equivalence for these representative and other assays.

Intended Use

The Bayer Immuno 1 System upgraded for laboratory automation capability will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation system will coordinate the scheduling, sample identification, and physical transfer of samples.

Device

Bayer Immuno 1" System Upgraded for Laboratory Automation Capability

Gabriel J. Murace, Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

9/21/98
Date

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Part Numbers
	CEA:	Reagents: T01-3184-51Calibrators: T03-3188-01
	FSH:	Reagents: T01-3086-51Calibrators: T03-3148-01
	Free T4:	Reagents: T01-3360-51Calibrators: T03-3401-01
	PSA:	Reagents: T01-3450-51Calibrators: T03-3541-01
	T3:	Reagents: T01-2949-01Calibrators: T03-2872-01
	T4:	Reagents: T01-3260-51Calibrators: T03-3174-01
	TSH:	Reagents: T01-2942-51Calibrators: T03-3568-01
	T-Uptake:	Reagents: T01-3036-51Calibrators: T03-3076-01

Predicate Device

Bayer Immuno 1™ System

Part Numbers

The part numbers are identical to those used for the Bayer Immuno 1 " System upgraded for laboratory automation capability.

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BAYER IMMUNO 1™ UPGRADED SYSTEM			BAYER IMMUNO 1™ METHOD SHEET
METHOD	MEAN(UNITS)	TOTALCV (%)	MEAN(UNITS)	TOTALCV (%)
CEA	1.54 ng/mL	3.3	2.9 ng/mL	2.3
	13.29 ng/mL	1.2	8.9 ng/mL	2.2
	63.43 ng/mL	1.4	18.2 ng/mL	1.8
FSH	9.4 mIU/mL	1.6	5.5 mIU/mL	3.2
	15.26 mIU/mL	1	12.3 mIU/mL	2.8
	47.51 mIU/mL	0.7	30.3 mIU/mL	2.8
FREE T4	0.83 ng/dL	4.1	0.36 ng/dL	15.4
	1.43 ng/dL	4.3	1.25 ng/dL	6.0
	3.06 ng/dL	4.7	4.35 ng/dL	3.1
PSA	2.89 ng/mL	3.1	0.05 ng/mL	0.007 ng/mL
	6.9 ng/mL	2.4	0.92 ng/mL	2.9
	26.41 ng/mL	2.4	2.68 ng/mL	3.1
			9.87 ng/mL	2.2
			23.02 ng/mL	3.4
			49.13 ng/mL	2.0
			96.38 ng/mL	2.5
T3	0.66 ng/mL	5.1	0.46 ng/mL	13.3
	1.78 ng/mL	2.4	1.34 ng/mL	6.0
	2.9 ng/mL	2	3.43 ng/mL	3.9
T4	3.31 µg/dL	1.6	4.7 µg/dL	3.6
	7.57 µg/dL	2.2	8.2 µg/dL	2.6
	14.12 µg/dL	1.2	15.7 µg/dL	2.5
TSH	0.55 µIU/mL	6.4	0.1 µIU/mL	13.0
	5.08 µIU/mL	1	1.3 µIU/mL	6.3
	32.73 µIU/mL	1.2	9.0 µIU/mL	2.0
			22.5 µIU/mL	1.8
T-UPTAKE	0.97	3.3	0.71	2.8
	1.03	3.1	1.03	2.6
	1.24	2.2	1.41	2.4

1. Precision for Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability:

Standard deviation

ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ

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2) Correlation:

COMPARISONMETHOD	NUMBEROFSAMPLES	REGRESSIONEQUATIONy =	CORRELATIONCOEFFICIENTr	STANDARDERRORSy.x	RANGE OFANALYTECONCENTRATION
CEA	360	1.01x - 0.01	0.998	0.116	0.4 - 16.4 ng/mL
FSH	360	0.99x + 0.02	0.999	0.841	0 - 145 mIU/mL
Free T4	355	0.99x + 0.04	0.988	0.042	0.26 - 1.98 ng/dL
PSA	200	1.00x + 0.01	1.000	0.066	0 - 20.3 ng/mL
T3	360	0.99x + 0.02	0.987	0.046	0.48 - 2.16 ng/mL
T4	356	0.98x + 0.07	0.997	0.141	3.7 - 16.4 µg/dL
TSH	360	0.99x + 0.02	1.000	0.108	0.23 - 77 µIU/mL
T-Uptake	358	0.98x + 0.03	0.991	0.019	0.61 - 1.41

y = Bayer Immuno 1™ System upgraded for laboratory automation capability

x = Bayer Immuno 1™ System

: :

: .

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 7 1998

Gabriel J. Muraca, Jr. Manager Requlatory Affairs BAYER CORPORATION 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: K983345 Trade Name: Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability Requlatory Class: II Product Code: JJE September 22, 1998 Dated: Received: September 23, 1998

Dear Mr. Muraca:

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 requlation 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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Page 2

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 Autman

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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Page 1 of 1 1. 1. 1. 1.

510(k) Number (if known): K983345

Device Name: Bayer Immuno 1™ System Upgrade for LAS

Indications For Use:

_ .

. .. . .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use
	Optional Format 1-2-96)

(Division Sign-Off)

Division of Clinical Laboratos ! 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 983345 1-2

Regulation Number and Section

§ 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.