K Number

Device Name

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

Manufacturer

ALKO DIAGNOSTIC CORP.

Date Cleared

1996-12-18

(148 days)

Product Code

KRZ

Regulation Number

864.8165

Intended Use

The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

Device Description

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation. The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye and Reference Standard). ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.

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

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a calibration standard solution, not a software or hardware device that would typically incorporate AI/ML. The description focuses on its chemical composition and equivalence to a predicate device. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
This device is an In Vitro Diagnostic Solution used for calibrating CO-Oximeters and Oximeters, not directly for therapeutic purposes.

Diagnostic

The device, tHb Cal Standard, is an in vitro diagnostic solution intended for calibrating total hemoglobin channels of IL CO-Oximeters and Oximeters. It is a calibrator, not a diagnostic device itself.

SaMD (Software as a Medical Device)

The device is described as an "In Vitro Diagnostic Solution" and a "Cal Standard," which are physical substances used for calibration, not software. The description mentions composition, packaging, and functional tests involving analyzers, all indicative of a physical product.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for "calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters." This indicates it's used in a laboratory setting to ensure the accuracy of instruments that measure components of blood.
Device Description: The description clearly states it is a "Class II (81KRZ) In Vitro Diagnostic Solution." The classification and the term "In Vitro Diagnostic Solution" directly identify it as an IVD.
Function: The device is a "Cal Standard," which is a type of reagent or material used to calibrate diagnostic instruments. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
Predicate Device: The predicate device is also described as a "Cal Dye and Reference Standard," further reinforcing its role in the calibration of diagnostic equipment.

All these points strongly indicate that the tHb Cal Standard is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

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

81KRZ

Device Description

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters. Instrumentation Laboratory Company is the original equipment manufacturer (OEM) of the analyzer and of predicate Cal Dye™ Reference Standard which is necessary for calibrating the total hemoglobin channel on the IL CO-Oximeters and/Oximeters.

The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dyeand Reference Standard).

ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.

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)

Functional tests where results were obtained on Instrumetation Laboratory CO-Oximeters/Oximeters with ALKO product and were compared with results obtained on the same analyzer calibrated with Instrumentation Labratory product.
Precision study where ALKO product was used on an Instrumetation Laboratory O Analyzer and samples were measured over 5 runs.
Comparative analysis where tHb Cal Standard and IL Cal Dye™ Reference Standard were measured and compared with the assayed tHb values.

Precision Data: Precision data were collected from the analysis of three levels of IL CO-OX controls (Human Hemoglobin based), 3 times per run, one run per day for 5 days, on a 482 analyzer calibrated with ALKO tHb Cal Standard. A separate calibration was performed prior to each run.
- Level 1: N=15, Mean=16.9, STD=0.1181, CV%=0.6993, Min=16.8, Max=17.2 (Total); N=5, Mean=16.9, STD=0.0646, CV%=0.3826, Min=16.8, Max=17.0 (Run to Run)
- Level 2: N=15, Mean=13.8, STD=0.1147, CV%=0.8340, Min=13.6, Max=13.9 (Total); N=5, Mean=13.8, STD=0.0806, CV%=0.5857, Min=13.6, Max=13.9 (Run to Run)
- Level 3: N=15, Mean=7.2, STD=0.0772, CV%=1.0758, Min=7.1, Max=7.4 (Total); N=5, Mean=7.2, STD=0.0533, CV%=0.7435, Min=7.1, Max=7.3 (Run to Run)
Comparative Data: Comparative data were collected from the analysis of ALKO and IL tHb Cal Standards measured on IL 282 and 482 Analyzers.
- On IL 282:
  - IL 33150, lot N0931981: N=15, Mean=14.7, STD=0.0653, CV%=0.4450, tHb min.-max.=14.6-14.8, Assay Value=14.8
  - ALKO A331-50, lot 10624: N=15, Mean=15.0, STD=0.0499, CV%=0.3316, tHb min.-max.=15.0-15.1, Assay Value=15.0
- On IL 482:
  - IL 33150, lot N1257163: N=15, Mean=14.9, STD=0.0730, CV%=0.4901, tHb min.-max.=14.8-15.0, Assay Value=14.9
  - ALKO A331-50, lot 50128: N=15, Mean=14.8, STD=0.0442, CV%=0.2993, tHb min.-max.=14.7-14.8, Assay Value=14.8
Functional Tests: Functional tests of ALKO tHb Cal Standard were performed on IL 282 and 482 Analyzers and compared to IL Cal Dye™ Reference Standard. Both analyzers were calibrated with ALKO and IL tHb Standards separately. Three levels of IL CO-OX controls (Human Hemoglobin based) were measured in triplicate.
- IL 282 Analyzer: Mean values for tHb (g/dL), %O2Hb, %COHb, %MetHb, O2 Ct (Vol%).
  - Calibrated with IL Cal Dye™ Reference Standard:
    - Level 1: 17.2, 39.3, 60.4, 0.2, 9.4
    - Level 2: 12.8, 96.3, 3.7, 0.5, 17.2
    - Level 3: 6.4, 76.0, 24.1, 0.2, 6.7
  - Calibrated with ALKO tHb Cal Standard:
    - Level 1: 17.4, 39.4, 60.4, 0.3, 9.5
    - Level 2: 13.0, 96.1, 4.0, 0.5, 17.4
    - Level 3: 6.5, 75.8, 24.3, 0.4, 6.8
  - Assayed Control Values:
    - Level 1: 16.6-17.6, 37.1-41.1, 58.6-62.0, -0.9-3.1, 8.5-10.5
    - Level 2: 12.3-13.3, 93.5-98.5, 1.9-5.3, -1.1-2.9, 16.3-18.7
    - Level 3: 6.0-7.0, 73.7-77.7, 22.1-25.5, -1.0-3.0, 6.2-7.4
- IL 482 analyzer: Mean values for tHb (g/dL), %O2Hb, %COHb, %MetHb, O2 Ct (Vol%), % RHb.
  - Calibrated with IL Cal Dye™ Reference Standard:
    - Level 1: 16.8, 39.0, 60.5, 0.1, 9.1, 0.4
    - Level 2: 13.7, 97.3, 2.2, 0.2, 18.5, 0.3
    - Level 3: 7.1, 77.3, 22.4, 0.2, 7.6, 0.1
  - Calibrated with ALKO tHb Cal Standard:
    - Level 1: 16.9, 39.1, 60.1, 0.4, 9.2, 0.4
    - Level 2: 13.8, 97.1, 2.1, 0.3, 18.6, 0.4
    - Level 3: 7.1, 77.2, 22.4, 0.2, 7.6, 0.3
  - Assayed Control Values:
    - Level 1: 16.6 to 17.6, 35.6 to 39.6, 59.6 to 63.0, -0.8 to 3.2, 8.1 to 10.1, -1.3 to 1.1
    - Level 2: 13.3 to 14.3, 93.4 to 98.4, 1.5 to 4.9, -0.9 to 3.1, 17.4 to 19.8, -1.5 to 0.9
    - Level 3: 6.7 to 7.7, 74.1 to 78.1, 21.0 to 24.4, -0.6 to 3.4, 7.1 to 8.3, -1.5 to 0.9

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.

(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(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 § 864.9.

Summary

DEC 1 8 1996

Image /page/0/Picture/1 description: The image shows the logo for ALKO Diagnostic Corporation. The logo consists of a black triangle with the word "ALKO" underneath it. Below the company name is the text "A Life Sciences International Company".

A Life Sciences International Company

K962864

510(k) Summary

tHb Cal Standard

for Instrumentation Laboratory CO-Oximeters and Oximeters.

ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products. ALKO has shown performance equivalence of its product to Instrumentation Laboratory Company's product in the following manner:

O Through functional tests where results were obtained on Instrumetation Laboratory CO-Oximeters/Oximeters with ALKO product and were compared with results obtained on the same analyzer calibrated with Instrumentation Labratory product.
Through a precision study where ALKO product was used on an Instrumetation Laboratory O Analyzer and samples were measured over _ 5 _ runs.
O Through a comparative analysis where tHb Cal Standard and IL Cal Dye™ Reference Standard were measured and compared with the assayed tHb values.

A summary of the results of these studies follows:

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SHEET 6 OF 33

Page 2/ ALKO 510 (k) Summary for IL Cal Dye™ Reference Standard

PERFORMANCE CHARACTERISTICS

1. Precision Data

Precision data were collected from the analysis of three levels of IL CO-OX controls (Human Hemoglobin based), 3 times per run, one run per day for 5 days, on a 482 analyzer calibrated with ALKO tHb Cal Standard. A separate calibration was performed prior to each run.

tHb
Level		N	Mean	STD	CV%	Min	Max
1	Total	15	16.9	0.1181	0.6993	16.8	17.2
	Run to Run	5	16.9	0.0646	0.3826	16.8	17.0
2	Total	15	13.8	0.1147	0.8340	13.6	13.9
	Run to Run	5	13.8	0.0806	0.5857	13.6	13.9
3	Total	15	7.2	0.0772	1.0758	7.1	7.4
	Run to Run	5	7.2	0.0533	0.7435	7.1	7.3

2. Comparative Data

Comparative data were collected from the analysis of ALKO and IL tHb Cal Standards measured on IL 282 and 482 Analyzers.

Instrument	Product P/N, Lot No	N	Mean	STD	CV%	tHb min.- max.	Assay Value
on IL 282	IL 33150, lot N0931981	15	14.7	0.0653	0.4450	14.6 - 14.8	14.8
	ALKO A331-50, lot 10624	15	15.0	0.0499	0.3316	15.0 - 15.1	15.0
on IL 482	IL 33150, lot N1257163	15	14.9	0.0730	0.4901	14.8 - 15.0	14.9
	ALKO A331-50, lot 50128	15	14.8	0.0442	0.2993	14.7 - 14.8	14.8

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3. Functional Tests

Functional tests of ALKO tHb Cal Standard were performed on IL 282 and 482 Analyzers and compared to IL Cal Dye™ Reference Standard. Both analyzers were calibrated with ALKO and IL tHb Standards separately. Three levels of IL CO-OX controls (Human Hemoglobin based) were measured in triplicate. The mean values are shown below.

| | | tHb(g/dL) | %O2Hb | %COHb | %MetHb | O2 Ct
(Vol%) |
|------------------------------------------------------------|---------|-----------|-----------|-----------|----------|-----------------|
| Calibrated
with IL Cal
Dye™
Reference
Standard | Level 1 | 17.2 | 39.3 | 60.4 | 0.2 | 9.4 |
| | Level 2 | 12.8 | 96.3 | 3.7 | 0.5 | 17.2 |
| | Level 3 | 6.4 | 76.0 | 24.1 | 0.2 | 6.7 |
| Calibrated
with ALKO
tHb Cal
Standard | Level 1 | 17.4 | 39.4 | 60.4 | 0.3 | 9.5 |
| | Level 2 | 13.0 | 96.1 | 4.0 | 0.5 | 17.4 |
| | Level 3 | 6.5 | 75.8 | 24.3 | 0.4 | 6.8 |
| Assayed
Control
Values | Level 1 | 16.6-17.6 | 37.1-41.1 | 58.6-62.0 | -0.9-3.1 | 8.5-10.5 |
| | Level 2 | 12.3-13.3 | 93.5-98.5 | 1.9-5.3 | -1.1-2.9 | 16.3-18.7 |
| | Level 3 | 6.0-7.0 | 73.7-77.7 | 22.1-25.5 | -1.0-3.0 | 6.2-7.4 |

a) IL 282 Analyzer

b) IL 482 analyzer

		tHb(g/dL)	%O2Hb	%COHb	%MetHb	O2 Ct (Vol%)	% RHb
Calibrated
with IL Cal
Dye™
Reference
Standard	Level 1	16.8	39.0	60.5	0.1	9.1	0.4
	Level 2	13.7	97.3	2.2	0.2	18.5	0.3
	Level 3	7.1	77.3	22.4	0.2	7.6	0.1
Calibrated
with ALKO
tHb Cal
Standard	Level 1	16.9	39.1	60.1	0.4	9.2	0.4
	Level 2	13.8	97.1	2.1	0.3	18.6	0.4
	Level 3	7.1	77.2	22.4	0.2	7.6	0.3
Assayed
ontrol
Values	Level 1	16.6 to
17.6	35.6 to
39.6	59.6 to
63.0	-0.8 to
3.2	8.1 to
10.1	-1.3 to
1.1
	Level 2	13.3 to
14.3	93.4 to
98.4	1.5 to
4.9	-0.9 to
3.1	17.4 to
19.8	-1.5 to
0.9
	Level 3	6.7 to 7.7	74.1 to
78.1	21.0 to
24.4	-0.6 to
3.4	7.1 to
8.3	-1.5 to
0.9

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ALKO Diagnostic Corporation . 333 Fiske Street . Holliston, MA . 01746-2048 . USA . Phone: (508) 429-4600 . Fax: (508) 429-4900

Page 4/ ALKO 510(k) Summary for Cal-Dye™ Reference Standard

Conclusion

ALKO manufactures products that serve as functional equivalents to consumable distributed by Original Equipment Manufacturer. All such products are manufactured with the intent of complying with the Good Manufacturing Practice Regulations.

As previously stated the product encompassed by this request serves as a functional equivalent to the product currently manufactured and marketed by Instrumentation Laboratory of Lexington, MA USA. We believe that Instrumentation Laboratory has received 510 (k) market approval given that they are currently distributing the IL CO-Oximeter instruments and related consumable domestically. The previously described labeling and performance verification should provide adequate documentation as to the equivalence of the ALKO Product.

I hope you find the documentation provided informative and helpful.

Janet A. McGrath

Regulatory Affairs

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