HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT by ELAN HOLDINGS, INC.

HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, potassium, chloride, urea, giucose, creatinine, calcium and total CO2.

HiChem® Calibrators 1, 2 and 3 for the SYNCHRON CX® DELTA and CX® CE® Systems are intended to establish points of reference that are used in the determination of values in the measurement of substances in specimens.

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HiChem® Calibrators 1, 2 and 3, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents method comparison study results as evidence of effectiveness and substantial equivalence to the predicate device. The implicit acceptance criteria appear to be the demonstration of strong linear correlation (high 'r' value) and minimal bias (slope 'b' close to 1.0 and intercept 'a' close to 0.0) between the HiChem® calibrators and the Beckman® calibrators across various analytes and specimen types.

Table of Performance (derived from the method comparison study):

Analyte	Specimen	Unit	Regression Statistics (n)	'a'	'b'	'r'	Range	Mean X (Predicate)	Mean Y (Device)
Calcium	Serum/Plasma	mg/dL	160	0.0	0.989	0.985	7.1 - 10.6	9.26	9.13
	Urine	mg/dL	74	-0.2	1.007	0.998	2.4 - 15.2	8.45	8.3
Chloride	Serum/Plasma	mmol/L	160	1.0	0.988	0.935	98.2 - 127.5	107.3	107.0
	Urine	mmol/L	78	-5.1	1.049	0.999	22.4 - 289	126.8	127.9
	CSF	mmol/L	44	-3.4	1.024	0.985	113.8 - 152.4	126.5	126.1
Potassium	Serum/Plasma	meq/L	160	0.13	0.969	1.000	3.20 - 10.82	5.02	5.00
	Urine	meq/L	80	0.01	0.993	1.000	3.48 - 136.0	50.5	50.2
Sodium	Serum/Plasma	meq/L	160	9.1	0.930	0.938	131.8 - 159.1	141.0	140.3
	Urine	meq/L	78	-0.3	1.000	1.000	16.9 - 288.1	118.2	117.8
Total CO2	Serum/Plasma	mmol/L	160	1.2	0.949	0.953	9.5 - 29.1	23.3	23.2
BUN	Serum/Plasma	mgN/dL	160	-0.3	0.987	0.999	4 - 126	19.0	18.4
	Urine	mgN/dL	79	0.9	0.979	1.000	6 - 142	76.2	75.4
Glucose	Serum/Plasma	mg/dL	159	-1.2	1.011	0.999	29 - 341	100.7	100.6
	Urine	mg/dL	81	-2.1	1.012	0.999	1 - 359	197.3	197.4
	CSF	mg/dL	45	1.0	0.973	0.999	3 - 186	81.9	80.7
Creatinine	Serum/Plasma	mg/dL	160	0.0	0.991	0.997	0.4 - 5.4	1.09	1.08
	Urine	mg/dL	79	-0.3	1.000	1.000	12.1 - 309.2	112.5	112.3

Summary of Device Performance against Implicit Acceptance Criteria:

The device consistently demonstrates strong linear correlation (r-values generally close to 1.0, with most >0.98 and only a few >0.93) and good agreement with the predicate device (slope 'b' generally close to 1.0 and intercept 'a' close to 0.0) across all tested analytes and specimen types. This performance suggests the device meets the implicit acceptance criteria for substantial equivalence to the predicate.

Study Details:

Sample sizes used for the test set and the data provenance:
- Sample Sizes (n):
  - Serum/Plasma: 159 or 160 for most analytes
  - Urine: 74-81 for most analytes
  - CSF: 44 or 45 for some analytes (Chloride, Glucose)
- Data Provenance:
  - Country of Origin: Not specified.
  - Retrospective or Prospective: Not explicitly stated, however, the phrase "were collected from adult patients and assayed" suggests a prospective collection for the purpose of this study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device (calibrators for laboratory instruments). The "ground truth" in this context is the analytical result obtained using the predicate device's calibrators on a controlled laboratory system. There are no human "experts" establishing a diagnostic ground truth.
Adjudication method for the test set:
Not applicable. This is a quantitative measurement comparison study, not one requiring adjudication of subjective interpretations.
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:
Not applicable. This is a study comparing analytical calibrators, not an AI-assisted diagnostic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in a sense, this is a standalone performance study of the calibrators. The performance shown directly reflects the analytical capability of the HiChem® calibrators in conjunction with the SYNCHRON CX® DELTA System, without human intervention in the measurement process itself, beyond operating the instrument. The results are compared against the predicate calibrators in the same system configuration.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this study is the analytical results obtained using the predicate calibrators (SYNCHRON® CX® Calibrators 1, 2 & 3) on the specified Beckman® SYNCHRON CX® DELTA System. This is a comparative study against an established, legally marketed calibrator.
The sample size for the training set:
Not applicable. This device is a calibrator, and its evaluation involves method comparison studies, not machine learning or AI models that require a separate training set.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.

Summary

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K99 28415

élan diagnostics

Image /page/0/Picture/2 description: The image is a black and white logo for "élan". The logo features a stylized letter "e" formed by multiple parallel lines that curve around to create the shape. To the left of the "e", there are several short, horizontal lines that resemble a stylized wing or speed lines. Below the graphic element, the word "élan" is written in a bold, sans-serif font, with an acute accent over the "e".

Summary of 510(k) Safety and Effectiveness Information

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.

HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, chloride, urea, glucose, creatinine, calcium and total CO2. The HiChem® Calibrator 1 Kit, Calibrator 2 Kit and Calibrator 3 Kit are substantially equivalent to the SYNCHRON® CX® Calibrators 1, 2 & 3, product nos. 465908, 465909 and 465910, manufactured by Beckman Coulter, Inc.

The effectiveness of the HiChem® Calibrators 1, 2 and 3 is shown by the following method comparison studies.

Method Comparison

Serum, plasma, urine and CSF were collected from adult patients and assayed using HiChem® and Beckman® calibrators, reagents and wash solutions on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression and the following statistics were obtained.

Analyte	Specimen	Unit	Regression Statistics				Summary Statistics
			n	a	b	r	range	mean X	mean Y
Calcium	Serum/Plasma	mg/dL	160	0.0	0.989	0.985	7.1 - 10.6	9.26	9.13
	Urine	mg/dL	74	-0.2	1.007	0.998	2.4 - 15.2	8.45	8.3
Chloride	Serum/Plasma	mmol/L	160	1.0	0.988	0.935	98.2 - 127.5	107.3	107.0
	Urine	mmol/L	78	-5.1	1.049	0.999	22.4 - 289	126.8	127.9
	CSF	mmol/L	44	-3.4	1.024	0.985	113.8 - 152.4	126.5	126.1
Potassium	Serum/Plasma	meq/L	160	0.13	0.969	1.000	3.20 - 10.82	5.02	5.00
	Urine	meq/L	80	0.01	0.993	1.000	3.48 - 136.0	50.5	50.2
Sodium	Serum/Plasma	meq/L	160	9.1	0.930	0.938	131.8 - 159.1	141.0	140.3
	Urine	meq/L	78	-0.3	1.000	1.000	16.9 - 288.1	118.2	117.8
Total CO2	Serum/Plasma	mmol/L	160	1.2	0.949	0.953	9.5 - 29.1	23.3	23.2
BUN	Serum/Plasma	mgN/dL	160	-0.3	0.987	0.999	4 - 126	19.0	18.4
	Urine	mgN/dL	79	0.9	0.979	1.000	6 - 142	76.2	75.4
Glucose	Serum/Plasma	mg/dL	159	-1.2	1.011	0.999	29 - 341	100.7	100.6
	Urine	mg/dL	81	-2.1	1.012	0.999	1 - 359	197.3	197.4
	CSF	mg/dL	45	1.0	0.973	0.999	3 - 186	81.9	80.7
Creatinine	Serum/Plasma	mg/dL	160	0.0	0.991	0.997	0.4 - 5.4	1.09	1.08
	Urine	mg/dL	79	-0.3	1.000	1.000	12.1 - 309.2	112.5	112.3

Wynn Stocking

Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics

20 August, 1999

510(k) Notification, HiChem® Calibrators 1, 2 & 3, page 81 is a division of Elan Pharmaceuticals

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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 8 1999

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821

Re: K992845

Trade Name: HiChem® Calibrator 1 Kit, Calibrator 2 Kit and Calibrator 3 Kit Regulatory Class: II Product Code: JIX Dated: August 20, 1999 Received: August 24, 1999

Dear Mr. Stocking:

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 (OS) 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 regulation 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to 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 Putman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K992845

Device Names:

HiChem® Calibrator 1 Kit, HiChem® Calibrator 2 Kit, and HiChem® Calibrator 3 Kit

Indications for Use:

These calibrators are intended for professional use only.

Respectfully,

Wynn Stocking

Wynn Stocking Regulatory Affairs Manager Elan Diagnostics

20 August, 1999

Sean Cooper

(Division Si
Division of Ciracal I shoratory Levices
510(k) Numb K992845

(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)

510(k) Notification, HiChem® Calibrators 1, 2 & 3 Elan Diagnostics, Brea, California

20 August, 1999 page 85 of 85

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.