K Number

Device Name

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY

Manufacturer

BAYER CORP.

Date Cleared

1998-12-07

(75 days)

Product Code

JJE

Regulation Number

862.2160

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Bayer Immuno 1™ System

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an upgrade to a laboratory automation system focused on hardware and software for communication and robotic sample transfer. There is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a laboratory automation system for coordinating the scheduling, sample identification, and physical transfer of samples for various laboratory tests. It is used in a laboratory setting and does not directly interact with patients for diagnosis or treatment.

Diagnostic

No
The device is described as an upgrade to a laboratory automation system, facilitating communication and robotic transfer of samples for various laboratory tests (CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake). While these tests can be used for diagnostic purposes, the device itself is focused on the automation of sample handling, not directly on interpreting medical images or data to provide a diagnosis. The "Intended Use" states it facilitates transfer of samples for "representative methods," implying it aids in the process of testing, not the diagnosis itself.

SaMD (Software as a Medical Device)

The device description explicitly states that both "Software and Hardware will facilitate communication and robotic transfer of samples". This indicates the device includes hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Bayer Immuno 1™ System upgraded for Laboratory Automation capability is an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the system facilitates the transfer and processing of samples for specific laboratory methods (CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake). These are all common laboratory tests performed on biological samples (likely blood or serum) to diagnose or monitor medical conditions.
Device Description: The device is described as a "System" upgraded for "Laboratory Automation Capability," implying it's a piece of equipment used in a laboratory setting for diagnostic purposes.
Performance Studies: The document describes performance studies comparing the upgraded system to the predicate device using metrics like precision and correlation coefficients. These are standard evaluations for IVD devices to demonstrate their analytical performance.
Predicate Device: The mention of a "Predicate Device" (Bayer Immuno 1™ System) is a strong indicator that this is a submission for a medical device, specifically an IVD, as predicate devices are used in regulatory submissions for devices that are substantially equivalent to previously cleared devices.

While the document focuses on the automation aspect and integration with a Laboratory Automation System, the core function of the Bayer Immuno 1™ System is to perform diagnostic tests on biological samples, which falls squarely under the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

JJE

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

CEA: Mean (Units) 1.54 ng/mL, Total CV (%) 3.3; Mean (Units) 13.29 ng/mL, Total CV (%) 1.2; Mean (Units) 63.43 ng/mL, Total CV (%) 1.4
FSH: Mean (Units) 9.4 mIU/mL, Total CV (%) 1.6; Mean (Units) 15.26 mIU/mL, Total CV (%) 1; Mean (Units) 47.51 mIU/mL, Total CV (%) 0.7
Free T4: Mean (Units) 0.83 ng/dL, Total CV (%) 4.1; Mean (Units) 1.43 ng/dL, Total CV (%) 4.3; Mean (Units) 3.06 ng/dL, Total CV (%) 4.7
PSA: Mean (Units) 2.89 ng/mL, Total CV (%) 3.1; Mean (Units) 6.9 ng/mL, Total CV (%) 2.4; Mean (Units) 26.41 ng/mL, Total CV (%) 2.4
T3: Mean (Units) 0.66 ng/mL, Total CV (%) 5.1; Mean (Units) 1.78 ng/mL, Total CV (%) 2.4; Mean (Units) 2.9 ng/mL, Total CV (%) 2
T4: Mean (Units) 3.31 µg/dL, Total CV (%) 1.6; Mean (Units) 7.57 µg/dL, Total CV (%) 2.2; Mean (Units) 14.12 µg/dL, Total CV (%) 1.2
TSH: Mean (Units) 0.55 µIU/mL, Total CV (%) 6.4; Mean (Units) 5.08 µIU/mL, Total CV (%) 1; Mean (Units) 32.73 µIU/mL, Total CV (%) 1.2
T-Uptake: Mean (Units) 0.97, Total CV (%) 3.3; Mean (Units) 1.03, Total CV (%) 3.1; Mean (Units) 1.24, Total CV (%) 2.2

Correlation:
Comparison Method and Correlation Coefficient (r) and Range of Analyte Concentration:

CEA: Number of Samples 360, Regression Equation y = 1.01x - 0.01, Correlation Coefficient r 0.998, Standard Error Sy.x 0.116, Range of Analyte Concentration 0.4 - 16.4 ng/mL
FSH: Number of Samples 360, Regression Equation y = 0.99x + 0.02, Correlation Coefficient r 0.999, Standard Error Sy.x 0.841, Range of Analyte Concentration 0 - 145 mIU/mL
Free T4: Number of Samples 355, Regression Equation y = 0.99x + 0.04, Correlation Coefficient r 0.988, Standard Error Sy.x 0.042, Range of Analyte Concentration 0.26 - 1.98 ng/dL
PSA: Number of Samples 200, Regression Equation y = 1.00x + 0.01, Correlation Coefficient r 1.000, Standard Error Sy.x 0.066, Range of Analyte Concentration 0 - 20.3 ng/mL
T3: Number of Samples 360, Regression Equation y = 0.99x + 0.02, Correlation Coefficient r 0.987, Standard Error Sy.x 0.046, Range of Analyte Concentration 0.48 - 2.16 ng/mL
T4: Number of Samples 356, Regression Equation y = 0.98x + 0.07, Correlation Coefficient r 0.997, Standard Error Sy.x 0.141, Range of Analyte Concentration 3.7 - 16.4 µg/dL
TSH: Number of Samples 360, Regression Equation y = 0.99x + 0.02, Correlation Coefficient r 1.000, Standard Error Sy.x 0.108, Range of Analyte Concentration 0.23 - 77 µIU/mL
T-Uptake: Number of Samples 358, Regression Equation y = 0.98x + 0.03, Correlation Coefficient r 0.991, Standard Error Sy.x 0.019, Range of Analyte Concentration 0.61 - 1.41

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Bayer Immuno 1™ System

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

BAYER IMMUNO 1™ UPGRADED SYSTEM			BAYER IMMUNO 1™ METHOD SHEET
METHOD	MEAN
(UNITS)	TOTAL
CV (%)	MEAN
(UNITS)	TOTAL
CV (%)
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

2) Correlation:

| COMPARISON
METHOD | NUMBER
OF
SAMPLES | REGRESSION
EQUATION
y = | CORRELATION
COEFFICIENT
r | STANDARD
ERROR
Sy.x | RANGE OF
ANALYTE
CONCENTRATION |
|----------------------|-------------------------|-------------------------------|---------------------------------|---------------------------|--------------------------------------|
| 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

: :

: .

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.

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

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)
--	--------------------------------------------------------	--

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