Predicate Devices

P860058

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay based on chemical reactions and optical detection, with results determined via a calibration curve. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.

Therapeutic

No.
This device is for in vitro quantitative determination of CEA, which aids in monitoring cancer patients by measuring CEA concentrations; it does not provide therapy.

Diagnostic

Yes

The device quantitatively determines carcinoembryonic antigen (CEA) in human samples, and these measurements aid in the management of cancer patients, indicating its use in diagnosing or monitoring disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical immunoassay process involving reagents, microparticles, magnetic capture, and a photomultiplier for measurement. This indicates a hardware-based system, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from the body but tested outside of it.
Purpose: The purpose is to "aid in the management of cancer patients by monitoring CEA concentrations," which is a diagnostic or monitoring function performed on a sample.
Device Description: The description details a laboratory-based immunoassay process involving reagents and an analyzer, which is typical of IVD devices.
Performance Studies: The performance studies describe evaluations of the device's analytical performance (precision, linearity, method comparison, etc.) using biological samples, which are standard for IVD validation.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (P860058) indicates that this device is being compared to a previously cleared IVD device, further confirming its classification.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma. Measurements of CEA aid in the management of cancer patients by monitoring CEA concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Product codes (comma separated list FDA assigned to the subject device)

DHX

Device Description

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C). • 1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal CEA-specific antibody (60 µL), and a monoclonal CEA-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex. • 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

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)

Precision:
Elecsys® CEA (Modified NCCLS ng/mL):
Control 1: N=60, Within-Run %CV=1.8, Total %CV=3.5
Control 2: N=60, Within-Run %CV=1.4, Total %CV=2.8
Pool 1: N=60, Within-Run %CV=1.7, Total %CV=3.2
Pool 2: N=60, Within-Run %CV=1.7, Total %CV=3.2
Pool 3: N=60, Within-Run %CV=1.4, Total %CV=3.4

Enzymun-Test CEA (Modified NCCLS ng/mL):
Low: N=120, Within-Run %CV=5.6, Total %CV=6.3
Mid: N=120, Within-Run %CV=3.7, Total %CV=4.1
High: N=120, Within-Run %CV=3.3, Total %CV=3.7

Lower Detection Limit: Elecsys® CEA: 0.2 ng/mL, Enzymun-Test CEA: 0.5 ng/mL

Linearity: Elecsys® CEA: 0.2 - 1000 ng/mL (with a deviation from a linear line of ±10%), Enzymun-Test CEA: 0.5 - 55 ng/mL (with a deviation from a linear line of ±10%)

Method Comparison (Vs Enzymun-Test® CEA):
Elecsys® CEA compared to Enzymun-Test® CEA (0 - 50 ng/mL):
Least Squares: y=1.25x - 0.86, r=0.976, SEE = 1.421, N=397
Passing/Bablok: y=1.22x - 0.69, r=0.976, SEE = 0.471, N=397

Elecsys® CEA compared to Enzymun-Test® CEA (0 - 600 ng/mL):
Least Squares: y=1.05x + 0.46, r=0.991, SEE = 6.093, N=446
Passing/Bablok: y=1.13x - 0.53, r=0.991, SEE = 0.714, N=446

Enzymun-Test CEA: Least Squares: y=0.97x - 0.064, r=0.989, SEE=1.649, N=69

Interfering substances (No interference at):
Bilirubin: Elecsys® CEA: 25 mg/dL, Enzymun-Test CEA: 64.5 mg/dL
Hemoglobin: Elecsys® CEA: 1000 mg/dL, Enzymun-Test CEA: 50 mg/dL
Lipemia: Elecsys® CEA: 1000 mg/dL, Enzymun-Test CEA: 1250 mg/dL
Biotin: Elecsys® CEA: 30 ng/mL, Enzymun-Test CEA: 40 ng/mL

Specificity (Non-specific cross reacting antigen % Cross-reactivity):
NCA 1: Elecsys® CEA:

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

P. 15
K964368

JUN 1 6 1997

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1.
Submitter name, address, contact	Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690, extension 8415

Contact Person: Mary Koning

Date Prepared: October 31, 1996 |
| 2.
Device name | Proprietary name: Elecsys® CEA Assay
Common name: Electrochemiluminescence assay for the determination of Carcinoembryonic antigen (CEA).
Classification name: Kit, Test, Carcinoembryonic antigen |
| 3.
Predicate device | The Boehringer Mannheim Elecsys® CEA is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test CEA (P860058). |
| 4.
Device Description | The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal CEA-specific antibody (60 µL), and a monoclonal CEA-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin. |
| 4.
Device
Description,
cont. | • The reaction mixture is aspirated into the measuring cell where the
microparticles are magnetically captured onto the surface of the electrode.
Unbound substances are then removed with ProCell. Application of a
voltage to the electrode then induces chemiluminescent emission which is
measured by a photomultiplier (0.4 second read frame).
• Results are determined via a calibration curve which is instrument-
specifically generated by 2-point calibration and a master curve provided
via the reagent bar code. |
| 5.
Intended use | Immunoassay for the in vitro quantitative determination of carcinoembryonic
antigen (CEA) in human serum and plasma.

Measurements of CEA aid in the management of cancer patients by
monitoring CEA concentrations.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on
the Boehringer Mannheim Elecsys 2010 immunoassay analyzer. |
| 6.
Comparison to
predicate
device | The Boehringer Mannheim Elecsys® CEA Assay is substantially equivalent
to other products in commercial distribution intended for similar use. Most
notably it is substantially equivalent to the currently marketed Enzymun-Test
CEA Assay (P860058).

The following table compares the Elecsys® CEA Assay with the predicate
device, Enzymun-Test CEA Assay (P860058):

Similarities:
• Intended Use: Immunoassay for the in vitro quantitative determination of
Carcinoembryonic Antigen (CEA). The assay is further indicated for serial
measurement of CEA to aid in the management of cancer patients.
• Solid phase binding principle: Streptavidin/Biotin
• Calibrators: Same formulation
• Assay standardization: 1st WHO Reference Standard 73/601
Continued on next page |

Continued on next page

1

.

510(k) Summary, Continued

2

510(k) Summary, Continued

Differences: 6. Comparison to predicate device, cont.

Feature	Elecsys® CEA	Enzymun CEA
Reaction test
principle	Electrochemiluminescence	ELISA/1-step sandwich assay
using streptavidin technology
Instrument
required	Elecsys® 2010	ES 300
Antibodies	Mouse/chimeric	Mouse/mouse
Sample
Material	Serum and Plasma	Serum
Calibration
Stability	A calibration is recommended
every 7 days if kit is not
consumed; 8 weeks with
same reagent lot if reagent is
consumed within 7 days.	A calibration is required every
run

Performance Characteristics:

Feature	Elecsys® CEA			Enzymun-Test CEA
Precision
Level	Modified NCCLS (ng/mL):			Modified NCCLS (ng/mL):
	Control 1	Control 2	Pool 1	Low	Mid	High
N	60	60	60	120	120	120
Within-Run	5.10	35.51	3.99	2.3	12.4	26.4
%CV	1.8	1.4	1.7	5.6	3.7	3.3
Total	5.10	35.51	3.99	2.3	12.4	26.4
%CV	3.5	2.8	3.2	6.3	4.1	3.7
Modified NCCLS (ng/mL):
	Pool 2	Pool 3
N	60	60
Within-Run	17.16	546.00
%CV	1.7	1.4
Total	17.16	546.00
%CV	3.2	3.4

Continued on next page

3

510(k) Summary, Continued

Performance Characteristics:

Comparison to predicate device, cont.

Feature	Elecsys® CEA	Enzymun-Test CEA
Lower Detection Limit	0.2 ng/mL	0.5 ng/mL
Linearity	0.2 - 1000 ng/mL (with a deviation from a linear line of ±10%)	0.5 - 55 ng/mL (with a deviation from a linear line of ±10%)
Method Comparison	Vs Enzymun-Test® CEA
0 - 50 ng/mL
Least Squares
y=1.25x - 0.86
r=0.976
SEE = 1.421
N=397

Passing/Bablok
y=1.22x - 0.69
r=0.976
SEE = 0.471
N=397

0 - 600 ng/mL
Least Squares
y=1.05x + 0.46
r=0.991
SEE = 6.093
N=446