The UniCel DxC SYNCHRON Systems are fully automated, computer-controlled clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).

Device Description

The UniCel DxC 600 and 800 Systems are the next generation of clinical chemistry analyzers in Beckman Coulter's SYNCHRON instrument family. The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with SYNCHRON Systems. The DxC instruments feature bar code identification of samples and reagents, Closed Tube Sampling, Obstruction Detection and Correction, and a dual carousel reagent storage compartment with an onboard capacity of 59 cartridges. Major system components include sample and reagent handling systems, bar code readers, modular chemistry sections, cartridge chemistry systems, and reagent storage compartment, supported by power and hydropneumatic utilities.

AI/ML Overview

The provided text describes the UniCel® DxC SYNCHRON® Clinical Systems (UniCel DxC 600 and 800) and their substantial equivalence to predicate devices, focusing on the performance of various chemistry assays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides summary performance data comparing the UniCel DxC 800 System to the SYNCHRON LX20 PRO (predicate device) through method comparison studies (slope, intercept, and correlation coefficient (R)) and imprecision studies (mean, within-run SD, within-run %CV, total SD, total %CV). The document implies that the acceptance criteria are met if the values obtained from the UniCel DxC 800 are similar to or within acceptable ranges compared to the predicate device, demonstrating "substantial equivalence."

A direct table of explicit acceptance criteria (e.g., "Slope must be between 0.95 and 1.05") is not explicitly stated in detail for each analyte. Instead, the reported performance (slope, intercept, R, and imprecision) is the evidence presented to demonstrate that the device meets the implied acceptance of being substantially equivalent to the predicate device.

Implied Acceptance Criteria (based on comparison to predicate performance) and Reported Device Performance:

Chemistry	Performance Metric	Implied Acceptance Criteria (e.g., close to 1 for slope, close to 0 for intercept, close to 1 for R, low %CV)	Reported UniCel DxC 800 Performance
Modular Assays		(Comparison to predicate)
NA	Slope	Expected ~1	0.987
	Intercept	Expected ~0	1.99
	R	Expected ~1	0.996
K	Slope	Expected ~1	0.993
	Intercept	Expected ~0	0.07
	R	Expected ~1	0.998
CL	Slope	Expected ~1	1.005
	Intercept	Expected ~0	-0.86
	R	Expected ~1	0.997
CO2	Slope	Expected ~1	1.043
	Intercept	Expected ~0	-1.05
	R	Expected ~1	0.994
CAL	Slope	Expected ~1	1.007
	Intercept	Expected ~0	-0.03
	R	Expected ~1	0.999
ALBm	Slope	Expected ~1	0.990
	Intercept	Expected ~0	0.05
	R	Expected ~1	1.000
BUNm	Slope	Expected ~1	0.985
	Intercept	Expected ~0	0.31
	R	Expected ~1	1.000
CREm	Slope	Expected ~1	1.037
	Intercept	Expected ~0	-0.01
	R	Expected ~1	1.000
GLUm	Slope	Expected ~1	1.006
	Intercept	Expected ~0	-0.11
	R	Expected ~1	1.000
PHOSm	Slope	Expected ~1	1.004
	Intercept	Expected ~0	0.02
	R	Expected ~1	0.999
TPm	Slope	Expected ~1	0.992
	Intercept	Expected ~0	0.08
	R	Expected ~1	0.996
Cartridge Assays		(Comparison to predicate)
CRPH	Slope	Expected ~1	1.024
	Intercept	Expected ~0	-0.03
	R	Expected ~1	0.999
FE	Slope	Expected ~1	1.002
	Intercept	Expected ~0	-0.16
	R	Expected ~1	1.000
LD	Slope	Expected ~1	1.005
	Intercept	Expected ~0	5.54
	R	Expected ~1	0.999
MG	Slope	Expected ~1	0.969
	Intercept	Expected ~0	0.04
	R	Expected ~1	0.999
PHE	Slope	Expected ~1	0.981
	Intercept	Expected ~0	0.02
	R	Expected ~1	0.998
URIC	Slope	Expected ~1	1.017
	Intercept	Expected ~0	-0.08
	R	Expected ~1	1.000
Qualitative Drug Assay (urine) - BENZ
Agreement	Expected 100%	100% (for positive and negative samples)
			(43 positive, 57 negative)
Imprecision (Various Chemistries at Low/High Control Levels)		Expected low %CV	Reported %CV (e.g., NA Low - 0.6% within-run, 0.9% total)

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

The "test set" consists of human biological fluid samples (serum, plasma, urine, cerebrospinal fluid, depending on the chemistry).

Sample Sizes (N) for Method Comparison Studies:
- Modular Assays: Range from 111 (BUNm) to 219 (CO2).
- Cartridge Assays: Range from 91 (PHE) to 181 (LD).
- Qualitative Drug Assay (BENZ): 43 positive samples and 57 negative samples (total 100).
Sample Sizes (N) for Imprecision Studies:
- The table states "Unicel 800 System Estimated Serum Imprecision (N=80)". This refers to 80 replicates per control level, per analyte, for the imprecision study.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies are internal ("Summary of Performance Data" is submitted by Beckman Coulter). The types of samples (serum, plasma, urine, CSF) indicate they are from human subjects, likely clinical samples. No indication of retrospective or prospective is given, but typically such studies for regulatory submissions would be prospectively collected or a well-defined retrospective cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For these types of in vitro diagnostic devices, "ground truth" is typically established by comparing the device's results to a legally marketed predicate device (as done here with the SYNCHRON LX20 PRO Systems) or a reference method. It's unlikely human experts were establishing a qualitative "ground truth" for quantitative chemistry assays in the way they might for an imaging AI device. The predicate device's measured values served as the reference for method comparison.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of analytical performance study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are interpreting images or making diagnoses, and discrepancies need to be resolved. For analytical performance of chemistry analyzers, the "accuracy" is determined by comparing measured values to a reference method (the predicate device) or known concentrations in controls/calibrators, not by human adjudication of qualitative results.

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

An MRMC comparative effectiveness study is not applicable to this type of device. This device is a clinical chemistry analyzer, not an AI or imaging diagnostic device that assists human readers in interpretation. Therefore, there is no "human reader improvement with AI vs without AI assistance" to report.

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

Yes, the performance data presented (method comparison and imprecision) represents the standalone performance of the UniCel DxC SYNCHRON Clinical Systems (the "algorithm/device only" in this context). The device directly measures chemical analytes in biological samples and provides quantitative or qualitative results without human-in-the-loop interpretation of the measurement itself. The human "in the loop" would be the lab technician operating the machine and interpreting the numerical results in the context of a patient's clinical picture.

7. The Type of Ground Truth Used

For the method comparison studies, the "ground truth" or reference was the results obtained from the predicate device (SYNCHRON LX®20 PRO Systems). The study aimed to show that the new device's measurements correlated well with, and were equivalent to, the established predicate device's measurements.

For the imprecision studies, the ground truth was the known concentrations/activities of the control materials used. The goal was to show that the device produced consistent and reproducible results around these known values.

8. The Sample Size for the Training Set

This information is not applicable/provided in the context of this traditional in vitro diagnostic device submission. These chemistry analyzers are not "trained" in the machine learning sense. Their performance is based on established electrochemical or photometric principles, reagent chemistry, and instrument calibration. There isn't a "training set" of data used to develop an algorithm in the way an AI model would be trained. The development and calibration processes are based on analytical chemistry principles and established quality control practices.

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

As noted above, there isn't a "training set" with ground truth in the AI sense for this device. The development and validation of the device would have involved:

Analytical Chemistry Principles: Calibrators with known, highly accurate concentrations are used to establish a calibration curve for each assay. These calibrators represent the "ground truth" for the instrument's quantitative measurements.
Quality Control Materials: Internal and external quality control materials with known target ranges are regularly run to verify the instrument's ongoing performance.
Predicate Device Comparison: The "ground truth" for demonstrating substantial equivalence for the new device's performance often comes from comparing its results to results generated by a legally marketed predicate device using the same or similar samples.

The "software development statement of compliance" mentions "Validation" and "acceptance criteria" for the software, but this refers to the functionality and reliability of the software controlling the instrument, not the training of an AI algorithm based on clinical data.

Summary

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K042291

NOV 1 2 2004

510(k) Summarv UniCel® DxC SYNCHRON® Clinical Systems

1.0 Submitted By:

Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

2.0 Date Submitted:

August 23. 2004

3.0 Device Name(s):

3.1 Proprietary Names UniCel® DxC 600 SYNCHRON® System UniCel® DxC 800 SYNCHRON® System

3.2 Classification Name Discrete photometric chemistry analyzer for clinical use [862.2160]

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	Docket #
UniCel® DxC 600SYNCHRON® System	SYNCHRON LX®20	Beckman Coulter, Inc.*	K965240,
UniCel® DxC 800SYNCHRON® System	PRO Systems		K011213

*Beckman Coulter, Inc., Brea, CA

5.0 Description:

6.0 Intended Use:

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Comparison to Predicate(s): 7.0

	Similarities
UniCel DxC600 and 800Systems	Intended Use	Same as Beckman CoulterSYNCHRON LX PRO Systems
	Fundamental Technologies
	Operational Environment
	System Architecture
	Optics/Reaction Subsystem
	Sample Handling Subsystem
	Chemistry Databases
	Reagents and Consumables
	Differences
	Reagent Storage Capacity	LX: 30 cartridgesDxC 600/800: 59 cartridges
	Reagent Handling Subsystem	LX: Teflon coated high nickel steel probesDxC 600/800: Extended length design
	Instrument Packaging	LX: 70 inch widthDxC 600: 62 inch widthDxC 600/800: New instrument skins
	Subsystem Designs	LX: OriginalDxC 600/800: Modified ModularChemistry, Power, and Hydropneumaticsubsystems
	Electronics	LX: OriginalDxC 600/800: New components toaddress obsolescence issues
	Operator Interface	LX: OriginalDxC 600/800: New key features
	Maintenance Procedures	LX: Chloride electrode resurfacingDxC 600/800: Replaceable chlorideelectrode tip
	Modular Chemistry Menu	LX: 11 chemistriesDxC 600: 6 chemistries
	Cartridge Chemistry Menu	LX: 83 chemistriesDxC 600/800: 86 chemistries

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision studies.

Modular	N	Slope	Intercept	R	Cartridge	N	Slope	Intercept	R
Assays					Assays
NA	164	0.987	1.99	0.996	CRPH	94	1.024	-0.03	0.999
K	161	0.993	0.07	0.998	FE	141	1.002	-0.16	1.000
CL	194	1.005	-0.86	0.997	LD	181	1.005	5.54	0.999
CO2	219	1.043	-1.05	0.994	MG	175	0.969	0.04	0.999
CAL	184	1.007	-0.03	0.999	PHE	91	0.981	0.02	0.998
ALBm	158	0.990	0.05	1.000	URIC	112	1.017	-0.08	1.000
BUNm	111	0.985	0.31	1.000
CREm	137	1.037	-0.01	1.000	Qualitative Drug Assay (urine)
GLUm	199	1.006	-0.11	1.000	BENZ	+	-	Agreement
PHOSm	198	1.004	0.02	0.999	+	43	0	100%
TPm	191	0.992	0.08	0.996	-	0	57

UniCel DxC 800 System vs. SYNCHRON LX20 PRO Serum Correlation Study

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Chemistry	ControlLevel	Mean	Within-runSD	Within-run%CV	TotalSD	Total%CV
NA	Low	114.8 mmmol/L	0.65	0.6	1.0	0.9
	High	155.6 mmol/L	0.96	0.6	1.32	0.9
K	Low	2.39 mmol/L	0.025	1.0	0.030	1.2
	High	7.30 mmol/L	0.056	0.8	0.063	0.9
CL	Low	81.8 mmol/L	0.77	0.9	1.00	1.2
	High	122.2 mmol/L	0.92	0.8	1.20	1.0
CO2	Low	12.2 mmol/L	0.39	3.2	0.49	4.0
	High	31.5 mmol/L	0.55	1.7	0.64	2.0
CALC	Low	7.5 mg/dL	0.07	0.9	0.08	1.0
	High	13.6 mg/dL	0.09	0.6	0.14	1.1
ALBm	Low	2.3 g/dL	0.04	1.9	0.06	2.4
	High	5.1 g/dL	0.05	1.0	0.06	1.1
BUNm	Low	6.8 mg/dL	0.4	6.2	0.5	6.9
	High	61.4 mg/dL	1.7	2.8	1.7	2.8
CREm	Low	0.5 mg/dL	0.04	8.7	0.04	9.0
	High	7.9 mg/dL	0.09	1.2	0.18	2.3
GLUm	Low	43.2 mg/dL	1.17	2.7	1.51	3.5
	High	379.0 mg/dL	2.11	0.6	4.88	1.3
PHOSm	Low	1.8 mg/dL	0.04	1.9	0.05	2.7
	High	6.5 mg/dL	0.06	1.0	0.11	1.7
TPm	Low	3.6 g/dL	0.08	2.4	0.09	2.5
	High	7.8 g/dL	0.08	1.0	0.10	1.2
BENZ	Low	413.1 mA/min	2.35	0.6	3.61	0.9
	High	470.0 mA/min	2.58	0.6	3.87	0.8
CRPH	Low	0.08 mg/dL	0.004	5.3	0.004	5.3
	High	7.59 mg/dL	0.135	1.8	0.153	2.0
FE	Low	65.0 µg/dL	1.82	2.8	2.14	3.3
	High	260.6 µg/dL	3.43	1.3	4.04	1.6
LD	Low	53 IU/L	2.3	4.4	2.4	4.5
	High	383 IU/L	4.1	1.1	6.5	1.7
MG	Low	1.2 mg/dL	0.01	1.2	0.02	2.1
	High	3.5 mg/dL	0.05	1.6	0.07	2.0
PHE	Low	9.3 µg/mL	0.19	2.1	0.25	2.7
	High	67.7 µg/mL	1.73	2.6	2.56	3.8
URIC	Low	2.5 mg/dL	0.05	2.0	0.05	2.1
	High	11.0 mg/dL	0.06	0.6	0.07	0.7

Unicel 800 System Estimated Serum Imprecision (N=80)

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye or a wave pattern. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically, with "BECKMAN" on top and "COULTER" below. The text is in a bold, sans-serif font, and the entire logo is in black against a white background.

August 9, 2004

Software Development Statement of Compliance

The UniCell DxC 600/800 SYNCHRONR Systems Software Version 1.0 was developed in compliance with internal procedure 12-0101 Software Development: Description of the Software Development Process 9/16/2002. Each phase of this software process model, Planning, Requirements, Design, Implementation and Validation was completed, verified and documented. Documentation is stored in the Software Central Project File Section 4.

The specific application of Procedure 12-0101 to UniCelR DxC 600/800 SYNCHRONR Systems Software Version 1.0 is detailed in the Software Development Plan. The software was validated according to the Software Validation Plan. Discrepancies between expected performance and final outcomes were managed through the software change control process in compliance with section 4 of Procedure 12-0101. The software validation report is included as an addendum to the Software Validation Plan.

An independent review of the software development documentation and validation reports ensured that each phase was completed as planned and the resulting product meets the acceptance criteria.

Zulia noble

Gayle A. Nobbs Center Manager - Software Development Laboratory Systems and Routine Testing Platform Development

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines.

Public Health Service

NOV 1 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92822-8000

K042291 Re: Trade/Device Name: UniCel® DxC 600 SYNCHRON® Clinical System UniCel® DxC 800 SYNCHRON® Clinical System Regulation Number: 21 CFR 862.1660 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, CEK CEO, CFJ, CGA, CGX, CGZ, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JHB, JIY, JJE, JXM, LFP Dated: October 13, 2004 Received: October 15, 2004

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter natification. The FDA finding of substantial equivalence of your device to a legally prehand redicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, n "Jou citins on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Cornelius B. Lorks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

UniCel® DxC 600 SYNCHRON® Clinical System UniCel® DxC 800 SYNCHRON® Clinical System

Indications for Use:

The UniCel DxC SYNCHRON Systems are fully automated, computercontrolled clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042291

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510(k) Number (if known):

Device Name:

SYNCHRON® Systems Total Protein (TP) Reagent

Indications for Use:

TP reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum or plasma.

Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders.

X = Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alle & L's
Division Sign Off

Division Sign-Off

Office of In Vitro Diganos Device Evaluation and S

510(k) K042291

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510(k) Number (if known):

Device Name:

SYNCHRON® Systems Total Protein (TPm) Reagent

Indications for Use:

TPm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems Protein Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum, plasma or cerebrospinal fluid (CSF).

Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders.

Over-the-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safety

510/k) ..

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510(k) Number (if known):

Image /page/9/Picture/2 description: The image shows a solid black rectangle. The rectangle is wide and short. The background is white.

Device Name:

SYNCHRON® Systems Potassium (K) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when ISE Electrolyte Buner FougenvaHRON LX® Systems, UniCel® DxC 600/800 used in Conjunotion RQUA Systems AQUA CAL 1, 2 and 3, are intended for Systems and of Normono of Potassium concentration in human serum, plasma or urine.

Potassium measurements are used in the diagnosis and treament of hypokalemia, hyperkalemia, renal failure, Addison's disease or other diseases involving electrolyte imbalance.

AND/OR -Prescription Use __ × (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mette Salz?

Office of In Vitro Diagnostic Device Evaluation and Safety

51080 K042291

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510(k) Number (if known):

Device Name:

SYNCHRON® Systems Phosphorus (PHOSm) Reagent

Indications for Use:

PHOSm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and the SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of inorganic Phosphorus concentration in human serum, plasma or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

AND/OR -Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberts
Division Sign-Off

ision Sian-

Office of Iri Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510/kj KOYa

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510(k) Number (if known):

Device Name:

SYNCHRON® Systems Lactate Dehydrogenase (LD) Reagent

Indications for Use:

LD reagent, when used in conjunction with SYNCHRON LX® Systems or UniCel® DxC 600/800 Systems, is intended for the quantitative determination of Lactate Dehydrogenase activity in human serum or plasma.

Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and acute metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Over-the-Counter Use _ AND/OR AND/OR AND/OR X X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Allie to S
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

53000 K0412291

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510(k) Number (if known):

Image /page/12/Figure/2 description: The image is a solid black rectangle. The rectangle is oriented horizontally and takes up a significant portion of the frame. The black color is uniform throughout the shape, with no visible texture or variation in tone.

Device Name:

SYNCHRON® Systems Glucose (GLUCm) Reagent

Indications for Use:

GLUCm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Prescription Use AND/OR AND/OR AND/OR Over-the-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51000

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510(k) Number (if known):

Image /page/13/Picture/2 description: The image shows a solid black shape against a white background. The shape is elongated and somewhat rectangular, with rounded edges. The black shape is opaque, and the white background is uniform. There are no other objects or details in the image.

Device Name:

SYNCHRON® Systems Creatinine (CREm) Reagent

Indications for Use:

CREm reagent, when used in conjunction with SYNCHRON LX® Systems, Chicin reagent, which desa and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

Creatinine measurements are used in the diagnosis and treatment of Orculinine incusarements and dialysis, and as a calculation basis for measuring other urine analytes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use AND/OR AND/OR (21 CFR 807 Subpart C)

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Abuts
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Office of In Vitro Diagnostic Device Evaluation and Safen

5100 K

{14}------------------------------------------------

510(k) Number (if known):

Image /page/14/Picture/2 description: The image shows a thick black brush stroke. The stroke is horizontal and slightly curved. The stroke is thicker on the left side and thinner on the right side.

Device Name:

SYNCHRON® Systems Creatinine (CREA) Reagent

Indications for Use:

CREA reagent, when used in conjunction with UniCel® DxC 600/800 OnEA Tougent) Theorom® Systems Multi Calibrator, is intended for the Systems and Officent of Creatinine concentration in human serum, plasma or urine.

Creatinine measurements are used in the diagnosis and treatment of renal Orcalline moutoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Over-the-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/ORD (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Albert Lutz
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Office of In Vitro Diagnostic Device Evaluation and Safery

510/k

{15}------------------------------------------------

510(k) Number (if known):

Image /page/15/Picture/2 description: The image is a solid black rectangle. There are no discernible features or details within the image. The rectangle appears to be uniformly filled with black color. There is nothing else visible in the image.

Device Name:

SYNCHRON® Systems Chloride (CL) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Chloride concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Chloride measurments are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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51011 KO4229

{16}------------------------------------------------

510(k) Number (if known)

Device Name:

SYNCHRON® Systems Albumin (ALB) Reagent

Indications for Use:

ALB reagent, when used in conjunction with UniCel® DxC 600/800 AEB Teagent, "Inter" asso Systems Multi Calibrator, is intended for the Systems and overmination of Albumin concentration in human serum or plasma.

Albumin measurements are used in the diagnosis and treatment of Albumin' measus primarily involving the liver and/or kidneys.

Over-the-Counter Use _ (21 CFR 807 Subpart C)

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Alberto S.
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Office of In Vitro Diagnostic Device Evaluation and Safery

5108k. K042291

{17}------------------------------------------------

510(k) Number (if known):

Device Name:

SYNCHRON® Systems Albumin (ALBm) Reagent

Indications for Use:

ALBm reagent, when used in conjunction with SYNCHRON LX® Systems, ALBH Teagent, when assu in c SYNCHRON® Systems Protein Calibrator, Unicel® DXC 800 Uystems and determination of Albumin concentration in human serum or plasma.

Albumin measurements are used in the diagnosis and treatment of Albumn - modelies primarily involving the liver and/or kidneys.

AND/OR -Over-the-Counter Use _ Prescription Use __ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Alberto S
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Office of In Vitro Diagnostic Device Evaluation and Safety

5300k K042291

{18}------------------------------------------------

510(k) Number (if known):

Device Name:

SYNCHRON® Systems High Sensitivity C-Reactive Protein (CRPH) Reagent

Indications for Use:

High Sensitivity CRPH reagent, when used in conjunction with SYNCHRON LX® PRO Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.

Measurement of C-Reactive protein aids in the evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases.

AND/OR AND/OR AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)

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Albert
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Office of In Vitro Diagnostic Device Evaluation and Safety

51000

{19}------------------------------------------------

510(k) Number (if known):

Image /page/19/Picture/2 description: The image shows a solid black shape against a white background. The shape is elongated and somewhat irregular, with a slightly curved top edge and a more jagged bottom edge. The black shape dominates the image, taking up a significant portion of the frame. There are no other discernible features or elements present in the image.

Device Name:

SYNCHRON® Systems Phenobarbital (PHE) Reagent

Indications for Use:

PHE reagent, when used in conjunction with SYNCHRON LX® Systems, PHE reagent, when used in conjunetion who Systems Drug Calibrator Unicel® DXC 600/000 Systems and of Phenobarbitation of Phenobarbital concentration in human serum or plasma.

Phenobarbital is indicated for the treatment of status epilepticus, febrile Phenobarbital is indicated for the croand mal and psychomotor), except
seizures and seizure disorders (grand mall and psychomotor, manitared for seizures and seizure disorders (grand than atherapy is monitored for suspected inadequate dose or toxicity.

Over-the-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Albert S
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Office of In Vitro Diagnostic Device Evaluation and Safety

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51000

{20}------------------------------------------------

510(k) Number (if known):

Device Name:

SYNCHRON® Systems Carbon Dioxide (CO2) Assay

Indications for Use:

ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 ISE Electrolyte Buffer and CO2 Acid reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 3, are intended for quantilative STNCHHON® Systems AGOT vide concentration in human serum or plasma.

Carbon dioxide measurements are used in the diagnosis and treatment of Carbon dioxide measurements as acra associated with changes in body acid-base balance.

Over-the-Counter Use AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Alberts S
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Office of In Vitro Diagnostic Device Evaluation and Safety

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KO4229 510/0

{21}------------------------------------------------

510(k) Number (if known)

Device Name:

SYNCHRON® Systems Calcium (CALC) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, 13E Electrolyte Dunct Tougent and Coast and Concerns, UniCel® DxC when used in oonjanon and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Calcium concentration in human serum, plasma or urine.

Calcium measurements are used in the diagnosis and treatment of Oalchum incusations a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Over-the-Counter Use X X AND/OR AND/OR AND/ORD Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Albert S
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Office of In Vitro Diagnostic Device Evaluation and Sofery

53906 K042291

{22}------------------------------------------------

510(k) Number (if known):

Image /page/22/Picture/2 description: The image shows a solid black rectangle. The rectangle is wide and short. The rectangle is centered on a white background.

Device Name:

SYNCHRON® Systems Magnesium (MG) Reagent

Indications for Use:

MG reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for DXC 600/000 Systems and of Magnesium concentration in human serum, plasma or urine.

Determination of magnesium is useful in assessing several diseases and Determination of magnesium is associated with uremia, dehydration, diabetic conditions. "Thgh magnesian" is "doosenated" intake of magnesium, such acroosis, Addison's diocuse, and the the marting induced by pregnancy). Low magnesium is associated with malabsorption syndrome, acute pancreatitis, hypoparathyroidism, chronic alcoholism and delirium tremens, chronic hypoparathyroldish, onromo-acontention, and protracted l.V. feeding.

Over-the-Counter Use _ AND/OR AND/OR AND/OR AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD A Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Albert S
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Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

5100

{23}------------------------------------------------

510(k) Number (if known):

Device Name:

SYNCHRON® Systems Sodium (NA) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when ISE Electronyto Baner FougHRON LX® Systems, UniCel® DxC 600/800 ased in Johnstich The Systems AQUA CAL 1, 2 and 3, are intended for Systems and of Henrination of Sodium concentration in human serum, plasma or urine.

Sodium measurements are used in the diagnosis and treatment of Souran modeles insipidus, adrenal hypertension, Addison's alidoster onliners, "than inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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Albetz S

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Office of In Vitro Diagnostic Device Evaluation and Safety

5309: k0422

{24}------------------------------------------------

510(k) Number (if known):

Image /page/24/Picture/2 description: The image shows a silhouette of two train cars. The train cars are connected to each other. The train cars are dark and the background is white.

Device Name:

SYNCHRON® Systems Uric Acid (URIC) Reagent

Indications for Use:

URIC reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for quantitative determination of Uric Acid concentration in human serum, plasma, or urine.

Uric acid measurements are used in the diagnosis and treatment of One acrd including increabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Over-the-Counter Use _ AND/OR AND/OR AND/ORD Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Mate Salz
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Office at in Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

6092291

{25}------------------------------------------------

510(k) Number (if known):

Image /page/25/Picture/2 description: The image is a black rectangle. It is a simple, solid shape with no discernible features or details. The rectangle is uniformly black, with no variations in color or texture. There is nothing else visible in the image.

Device Name:

SYNCHRON® Systems Iron (FE) Reagent

Indications for Use:

FE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® FE feagent, when used in oonjanenen was Systems FE/IBCT Calibrator Kit, is intended for the quantitative determination of Iron in human serum or heparinized plasma.

Alterations in iron and total iron binding capacity levels result from changes in Anterations in from and tellar and release mechanisms. Such changes are iroli intake, absorphon, oterage, dysfunctions including anemias, nephrosis, mulcative of a Wide Yango of and total iron binding capacity measurements cirriosis and ficpatitive diagnosis because they are interrelated. Tietz has are important for donnary of these relationships and the patterns of iron/total iron binding capacity associated with various disease states.

Over-the-Counter Use __ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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KO42291 5101

{26}------------------------------------------------

510(k) Number (if known):

Device Name:

SYNCHRON® Systems Benzodiazepine (BENZ) Reagent

Indications for Use:

BENZ reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC
enting States of the Concess of Archives of Abuse, Tosting, (DAT), Urin BENZ Feagent, when used in Conjunton than of Pennsodiaroping in human 600/800 Systems, and STNCTHON® Oystems Drago of Benzodiazepine in human urine at a cutoff value of 200 ng/mL (oxazepam).

The BENZ assay provides a rapid screening procedure for determining the presence of The BENZ assay provides a rapid sereching processionalytical result; a positive, positive, positive, positive, positive, positive, positive, positive, positive, positive, pos the analyte in urine. This lest provides only a provinces generally accepted nonresult by this assay Should Bo January Boging (TCC), gas chromatography (TCC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.

Clinical consideration and professional judgement should be applied to any drug of Clinical consideration when preliminary positive results are used.

Benzodiazepines are a class of central nervous system depressants that are used as Benzodiazepines are a Class of Central nervous of Stonings include chlordiazepoxide, Sedatives and Tryphotics. The Benzonials of Measurements of benzodiazepines diazepani, Oxazepan, hardzepain, and in the diagnosis and treatment of benzodiazepine on the STNCHHON® Systems are assessme of benzodiazepines to ensure appropriate therapy.

× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (21 CFR 807 Subpart C)

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Office of In Vir. Leaguesti. Device Evaluation and Salar

53095 K042291

{27}------------------------------------------------

510(k) Number (if known):

10.1002/adma.201806631

Device Name:

SYNCHRON® Systems Urea Nitrogen (BUNm or UREAm) Reagent

Indications for Use:

BUNm or UREAm reagent, when used in conjunction with SYNCHRON LX®
CALL CAL BUNM or UREAM reagent, when assum systems and SYNCHRON® Systems AQUA CAL
Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL Systems, Unicel® DXO 600 Oystems and C letermination of Urea Nitrogen or T, Z and S, Is Intended for the quarnitulity student or urine. The system can be Orea concentration in haman octains, present in default units of mg/dL or urea in default units of mmol/L.

Urea nitrogen or urea measurements are used in the diagnosis and Orca "hitrogo-netain renal and metabolic diseases.

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Office of In this Diagnostic Device Evaluation and Safety

Page 1 of 1

KO4229 110%

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.