K Number

Device Name

HCL - 200 BIOCHEMISTRY ANALYZER

Manufacturer

HCL LABORATORY SYSTEMS, INC.

Date Cleared

1997-01-22

(79 days)

Product Code

JJF CDQ CDT CEK CEO CFJ CFR CGS CGX CIG CIT CIX CKA DCN JFJ JQB KNK

Regulation Number

862.2170

Intended Use

The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.

Device Description

The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules: - The liquid handling system includes compartments of reagents and samples as well as the pipetting unit. - The reaction module includes the cuvette turntable to which samples and reagents are transferred. A photometer to monitor reaction response is also contained in this unit. Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.

More Information

Contact

Type

Center

Panel

Date Received

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Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K851172

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated chemistry analyzer with a liquid handling system, reaction module, and photometer. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies rely on standard NCCLS protocols for evaluating analytical performance, not AI/ML model validation.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) multichannel chemistry analyzer, which is used to analyze samples, not to treat or directly manage a patient's condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer."

SaMD (Software as a Medical Device)

The device description clearly outlines physical hardware components (liquid handling system, reaction module, photometer) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The very first line explicitly states, "The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer." This is the most direct confirmation.
Device Description: The description further reinforces this by calling it an "automated discrete random access in vitro diagnostic multichannel chemistry analyzer."
Functionality: The description of the device's components (liquid handling system, reaction module with photometer) and its purpose (monitoring reaction response) aligns with the typical function of an in vitro diagnostic chemistry analyzer, which analyzes biological samples outside of the body to aid in diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.

Product codes

Not Found

Device Description

The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules:

The liquid handling system includes compartments of reagents and samples as well as the pipetting . unit.
The reaction module includes the cuvette turntable to which samples and reagents are transferred. A . photometer to monitor reaction response is also contained in this unit.

Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.

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)

NCCLS evaluation protocols were used to demonstrate substantially equivalent performance between the HCL-200 and the predicate device. NCCLS Documents used in the evaluation of HCL-200 and the comparison to the Roche COBAS MIRA are listed below:

NCCLS Document Number	Document Title
EP 10 - T2 Vol. 13 No, 10	Preliminary Evaluation of Quantitative Clinical Laboratory Methods, Second Edition
EP6-P Vol. 6 No. 18	Evaluation of the Linearity of Quantitative Analytical Methods
EP5 - T2 Vol. 12, No.4	Evaluation of Precision Performance of Clinical Chemistry Devices, Second Edition
EP9 - T Vol. 13 No. 4	Method Comparison and Bias Estimation Using Patient Samples.

Method protocols (applications) for OEM supplied reagents were developed on the instrument after a two week device familiarization period as described in the NCCLS Documents. Preliminary evaluations using NCCLS EP 10 - T2 were run on each reagent in order to optimize application parameters.

A summary of pertinent statistical results for various reagents is presented in the tables:

Albumin:

Linearity: N: 5, Linear Range: 2 TO 8.5 g/dL
Simple Precision: N: 20, Normal: CV: 1.8%, Abnormal CV: 1.7%
Complex Precision: N: 80, Normal: CV: 8%, Abnormal CV: 6.4%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.000, Intercept [b]: -0.03, Correlation Coeff. [r]: 0.987

ALT (GPT):

Linearity: N: 7, Linear Range: 0 to 650 U/L
Simple Precision: N: 20, Normal: CV: 3%, Abnormal CV: 1.5%
Complex Precision: N: 80, Normal: CV: 4.6%, Abnormal CV: 2.1%
Comparison to Predicate (COBAS MIRA): N: 104, Slope [m]: 1.08, Intercept [b]: 0.6, Correlation Coeff. [r]: 0.998

Amylase:

Linearity: N: 9, Linear Range: 0 to 2500 U/L
Simple Precision: N: 20, Normal: CV: 4.6%, Abnormal CV: 1.7%
Complex Precision: N: 80, Normal: CV: 5.0%, Abnormal CV: 3.5%
Comparison to Predicate (COBAS MIRA): N: 101, Slope [m]: 1.09, Intercept [b]: -2.8, Correlation Coeff. [r]: 0.999

AST (GOT):

Linearity: N: 6, Linear Range: 0 to 650 U/L
Simple Precision: N: 20, Normal: CV: 3.5%, Abnormal CV: 2.6%
Complex Precision: N: 80, Normal: CV: 6.1%, Abnormal CV: 4.6%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.05, Intercept [b]: -0.6, Correlation Coeff. [r]: 0.997

Bilirubin, Total:

Linearity: N: 6, Linear Range: 0 to 20 mg/dL
Simple Precision: N: 20, Normal: CV: 2.8%, Abnormal CV: 1.5%
Complex Precision: N: 80, Normal: CV: 7.3%, Abnormal CV: 9.0%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 0.902, Intercept [b]: 0.11, Correlation Coeff. [r]: 0.993

BUN, Rate:

Linearity: N: 5, Linear Range: 0 to 125mg/dL
Simple Precision: N: 20, Normal: CV: 4.1%, Abnormal CV: 1.9%
Complex Precision: N: 80, Normal: CV: 5.8%, Abnormal CV: 5.2%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 0.948, Intercept [b]: 1.1, Correlation Coeff. [r]: 0.996

CK NAD, Imidazole:

Linearity: N: 8, Linear Range: 0 to 2100 U/L
Simple Precision: N: 20, Normal: CV: 2.3%, Abnormal CV: 2.3%
Complex Precision: N: 80, Normal: CV: 4.6%, Abnormal CV: 2.1%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.034, Intercept [b]: 5.6, Correlation Coeff. [r]: 0.999

Creatinine, (Jaffe):

Linearity: N: 5, Linear Range: 0 to 12.5 mg/dL
Simple Precision: N: 20, Normal: CV: 2.45%, Abnormal CV: 1.9%
Complex Precision: N: 80, Normal: CV: 7.2%, Abnormal CV: 3.1%
Comparison to Predicate (COBAS MIRA): N: 103, Slope [m]: 0.994, Intercept [b]: 0.045, Correlation Coeff. [r]: 0.997

CRP:

Linearity: Not applicable. Limits of Standard Curve.
Simple Precision: N: 20, Normal: CV: 6.3%, Abnormal CV:1.9%
Complex Precision: N: 80, Normal: CV: 6.7%, Abnormal CV: 2.6%
Comparison to Predicate (COBAS MIRA): N: 100, Correlation Coeff: [r]: 0.992

GGT:

Linearity: N: 8, Linear Range: 5 to 129 mg/dL
Simple Precision: N: 20, Normal: CV: 2.9%, Abnormal CV: 1.3%
Complex Precision: N: 80, Normal: CV: 5.9%, Abnormal CV:2.2%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.07, Intercept [b]: -0.9, Correlation Coeff: [r]: 0.999

Glucose, Hexokinase UV:

Linearity: N: 5, Linear Range: 0 to 600 mg/dL
Simple Precision: N: 20, Normal: CV: 2.6%, Abnormal CV: 2.3%
Complex Precision: N: 80, Normal: CV: 1.0%, Abnormal CV: 2.9%
Comparison to Predicate (COBAS MIRA): N: 400, Slope [m]:0.998, Intercept [b]: 7.5, Correlation Coeff: [r]: 0.992

LDH-L:

Linearity: N: 9, Linear Range: 0 to 1000 U/L
Simple Precision: N: 20, Normal: CV: 2.1%, Abnormal CV: 0.5%
Complex Precision: N: 80, Normal: CV: 2.8%, Abnormal CV: 1.9%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.06, Intercept [b]: 16.2, Correlation Coeff: [r]: 0.992

Phosphorus:

Linearity: N: 6, Linear Range: 0 to 15.0 mg/dL
Simple Precision: N: 20, Normal: CV: 2.9%, Abnormal CV: 1.2%
Complex Precision: N: 80, Normal: CV: 5.5%, Abnormal CV: 3.1%
Comparison to Predicate (COBAS MIRA): N: 111, Slope [m]: 1.06, Intercept [b]: 0.0, Correlation Coeff: [r]: 0.985

Total Protein:

Linearity: N: 5, Linear Range: 0 to 12 g/dL
Simple Precision: N: 20, Normal: CV: 1.6%, Abnormal CV: 0.9%
Complex Precision: N: 80, Normal: CV: 2.4%, Abnormal CV: 1.9%
Comparison to Predicate (COBAS MIRA): N: 102, Slope [m]: 1.05, Intercept [b]: -0.09, Correlation Coeff: [r]: 0.983

Triglycerides GPO:

Linearity: N: 5, Linear Range: 0 to 1000 mg/dL
Simple Precision: N: 20, Normal: CV: 2.8%, Abnormal CV: 1.6%
Complex Precision: N: 80, Normal: CV: 4.2%, Abnormal CV: 3.3%
Comparison to Predicate (COBAS MIRA): N: 102, Slope [m]: 1.025, Intercept [b]: -2.5, Correlation Coeff: [r]: 0.994

Uric Acid:

Linearity: N: 5, Linear Range: 0 to 20 mg/dL
Simple Precision: N: 20, Normal: CV: 1.7%, Abnormal CV: 1.8%
Complex Precision: N: 80, Normal: CV: 4.2%, Abnormal CV: 4.8%
Comparison to Predicate (COBAS MIRA): N: 100, Slope [m]: 1.02, Intercept [b]: -0.25, Correlation Coeff: [r]: 0.987

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

Key metrics presented are Correlation Coeff. [r], Slope [m], Intercept [b] for comparison to predicate, and CV for precision studies. No sensitivity, specificity, PPV, or NPV are explicitly stated.

Predicate Device(s)

K851172

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.2170 Micro chemistry analyzer for clinical use.

(a)
Identification. A micro 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. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(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

K964409

HCL Laboratory Systems, Inc. 510(k) Notification for HCL -200

JAN 22 1997

510 (k) Summary of Safety and Effectiveness

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS OF THE HCL-200 CLINICAL CHEMISTRY ANALYZER:

Submitted by:

Gregory M. Hearne Executive Vice President HCL Laboratory Systems Inc. 362 Camino Bailen Escondido, CA 92029 Telephone: (619) 738 - 8371. FAX: (619) 738 - 8371.

Identification:

Trade Name: HCL 200 Biochemistry Analyzer. .
. Common or usual name: Clinical Chemistry Analyzer
Classification name: Micro Chemistry Analyzer for Clinical Use. .

Description:

The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules:

The liquid handling system includes compartments of reagents and samples as well as the pipetting . unit.
The reaction module includes the cuvette turntable to which samples and reagents are transferred. A . photometer to monitor reaction response is also contained in this unit.

Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.

Intended Use:

The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.

Technological Characteristics Compared to the Predicate Device

The functions of the HCL-200 and the COBAS MIRA [510 (k) K851172] are fundamentally the same. The basic physical principles for measurement of radiant energy, absorbed or transmitted, under controlled conditions are the same. Both instruments are automated interference filter photometers capable of measuring monochromatic light with wavelengths between 340 and 700 mm.

Substantial Equivalence and Summary Performance Data:

Table 3 NCCLS Protocols Used in Evaluation/ Comparison
NCCLS Document Number	Document Title
EP 10 - T2
Vol. 13 No, 10	Preliminary Evaluation of Quantitative Clinical
Laboratory Methods, Second Edition
EP6-P
Vol. 6 No. 18	Evaluation of the Linearity of Quantitative
Analytical Methods
EP5 - T2
Vol. 12, No.4	Evaluation of Precision Performance of Clinical
Chemistry Devices, Second Edition
EP9 - T
Vol. 13 No. 4	Method Comparison and Bias Estimation Using
Patient Samples.

Method protocols (applications) for OEM supplied reagents listed below were developed on the instrument after a two week device familiarization period as described in the NCCLS Documents. Preliminary evaluations using NCCLS EP 10 - T2 were run on each reagent in order to optimize application parameters.

| REAGENT NAME | 510k Number | REAGENT NAME | 510k Number | REAGENT NAME | LINEARITY | SIMPLE PRECISION | COMPLEX PRECISION | COMPARISON TO
PREDICATE (COBAS MIRA) |
|---------------------|-------------|---------------------------|-------------|---------------------|---------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Albumin | K831585 | CRP | K902593 | Albumin | Number [N]: 5
Linear Range:
2 TO 8.5 g/dL | Number [N]: 20
Normal: CV: 1.8%
Abnormal CV: 1.7% | Number [N]: 80
Normal: CV: 8%
Abnormal CV: 6.4% | Number [N]: 100
Slope [m]: 1.000
Intercept [b]: -0.03
Correlation Coeff. [r]: 0.987 |
| ALT (GPT) | K820525 | GGT | K905085 | ALT (GPT) | Number [N]: 7
Linear Range:
0 to 650 U/L | Number [N]: 20
Normal: CV: 3%
Abnormal CV: 1.5% | Number [N]: 80
Normal: CV: 4.6%
Abnormal CV: 2.1% | Number [N]: 104
Slope [m]: 1.08
Intercept [b]: 0.6
Correlation Coeff. [r]: 0.998 |
| Amylase | K861718 | Glucose, Hexokinase
UV | K801765 | Amylase | Number [N]: 9
Linear Range:
0 to 2500 U/L | Number [N]: 20
Normal: CV: 4.6%
Abnormal CV: 1.7% | Number [N]: 80
Normal: CV: 5.0%
Abnormal CV: 3.5% | Number [N]: 101
Slope [m]: 1.09
Intercept [b]: -2.8
Correlation Coeff. [r]: 0.999 |
| AST (GOT) | K820270 | LDH-L | K822312 | AST (GOT) | Number [N]: 6
Linear Range:
0 to 650 U/L | Number [N]: 20
Normal: CV: 3.5%
Abnormal CV: 2.6% | Number [N]: 80
Normal: CV: 6.1%
Abnormal CV: 4.6% | Number [N]: 100
Slope [m]: 1.05
Intercept [b]: -0.6
Correlation Coeff. [r]: 0.997 |
| Bilirubin, Total | K841892 | Phosphorus | K870776 | Bilirubin, Total | Number [N]: 6
Linear Range:
0 to 20 mg/dL | Number [N]: 20
Normal: CV: 2.8%
Abnormal CV: 1.5% | Number [N]: 80
Normal: CV: 7.3%
Abnormal CV: 9.0% | Number [N]: 100
Slope [m]: 0.902
Intercept [b]: 0.11
Correlation Coeff. [r]: 0.993 |
| BUN, Rate | K812417 | Total Protein | K841466 | BUN, Rate | Number [N]: 5
Linear Range:
0 to 125mg/dL | Number [N]: 20
Normal: CV: 4.1%
Abnormal CV: 1.9% | Number [N]: 80
Normal: CV: 5.8%
Abnormal CV: 5.2% | Number [N]: 100
Slope [m]: 0.948
Intercept [b]: 1.1
Correlation Coeff. [r]: 0.996 |
| CK NAD, Imidazole | K905084/A | Triglycerides GPO | K842029/A | CK NAD, Imidazole | Number [N]: 8
Linear Range:
0 to 2100 U/L | Number [N]: 20
Normal: CV: 2.3%
Abnormal CV: 2.3% | Number [N]: 80
Normal: CV: 4.6%
Abnormal CV: 2.1% | Number [N]: 100
Slope [m]: 1.034
Intercept [b]: 5.6
Correlation Coeff. [r]: 0.999 |
| Creatinine, (Jaffe) | K840872 | Uric Acid | K812641 | Creatinine, (Jaffe) | Number [N]: 5
Linear Range:
0 to 12.5 mg/dL | Number [N]: 20
Normal: CV: 2.45%
Abnormal CV: 1.9% | Number [N]: 80
Normal: CV: 7.2%
Abnormal CV: 3.1% | Number [N]: 103
Slope [m]: 0.994
Intercept [b]: 0.045
Correlation Coeff. [r]: 0.997 |

A summary of pertinent statistical results are presented in the table on the following two (2) pages:

HCL Laboratory Systems, Inc.

510(k) Notification for HCL -200

ﺔ ﺍﻟﻤﺮﺍﺟﻊ

트

HCL Laboratory Systems, Inc.
510(k) Notification for HCL -200

REAGENT NAME	LINEARITY	SIMPLE PRECISION	COMPLEX PRECISION	COMPARISON TO PREDICATE (COBAS MIRA)
CRP	Number [N]:
Linear Range: not applicable.
Limits of Standard Curve:	Number [N]: 20
Normal: CV: 6.3%
Abnormal CV:1.9%	Number [N]: 80
Normal: CV: 6.7%
Abnormal CV: 2.6%	Number [N]: 100
Slope [m]:
Intercept [b]:
Correlation Coeff: [r]: 0.992
GGT	Number [N]: 8
Linear Range:
5 to 129 mg/dL	Number [N]: 20
Normal: CV: 2.9%
Abnormal CV: 1.3%	Number [N]: 80
Normal: CV: 5.9%
Abnormal CV:2.2%	Number [N]: 100
Slope [m]: 1.07
Intercept [b]: -0.9
Correlation Coeff: [r]: 0.999
Glucose, Hexokinase UV	Number [N]: 5
Linear Range:
0 to 600 mg/dL	Number [N]: 20
Normal: CV: 2.6%
Abnormal CV: 2.3%	Number [N]: 80
Normal: CV: 1.0%
Abnormal CV: 2.9%	Number [N]: 400
Slope [m]:0.998
Intercept [b]: 7.5
Correlation Coeff: [r]: 0.992
LDH-L	Number [N]: 9
Linear Range:
0 to 1000 U/L	Number [N]: 20
Normal: CV: 2.1%
Abnormal CV: 0.5%	Number [N]: 80
Normal: CV: 2.8%
Abnormal CV: 1.9%	Number [N]: 100
Slope [m]: 1.06
Intercept [b]: 16.2
Correlation Coeff: [r]: 0.992
Phosphorus	Number [N]: 6
Linear Range:
0 to 15.0 mg/dL	Number [N]: 20
Normal: CV: 2.9%
Abnormal CV: 1.2%	Number [N]: 80
Normal: CV: 5.5%
Abnormal CV: 3.1%	Number [N]: 111
Slope [m]: 1.06
Intercept [b]: 0.0
Correlation Coeff: [r]: 0.985
Total Protein	Number [N]: 5
Linear Range:
0 to 12 g/dL	Number [N]: 20
Normal: CV: 1.6%
Abnormal CV: 0.9%	Number [N]: 80
Normal: CV: 2.4%
Abnormal CV: 1.9%	Number [N]: 102
Slope [m]: 1.05
Intercept [b]: -0.09
Correlation Coeff: [r]: 0.983
Triglycerides GPO	Number [N]: 5
Linear Range:
0 to 1000 mg/dL	Number [N]: 20
Normal: CV: 2.8%
Abnormal CV: 1.6%	Number [N]: 80
Normal: CV: 4.2%
Abnormal CV: 3.3%	Number [N]: 102
Slope [m]: 1.025
Intercept [b]: -2.5
Correlation Coeff: [r]: 0.994
Uric Acid	Number [N]: 5
Linear Range:
0 to 20 mg/dL	Number [N]: 20
Normal: CV: 1.7%
Abnormal CV: 1.8%	Number [N]: 80
Normal: CV: 4.2%
Abnormal CV: 4.8%	Number [N]: 100
Slope [m]: 1.02
Intercept [b]: -0.25
Correlation Coeff: [r]: 0.987

Claim of Substantial Equivalence to Predicate Device

The safety and effectiveness of the HCL-200 Clinical Chemistry Analyzer is evidenced by:

Its equivalent performance to the predicate device, the Roche COBAS MIRA, as summarized in table 1. 5 above and,
the fact that the two devices are virtually identical in terms of their use of basic principles of radiant 2. energy measurement, automated liquid handling and data management capabilities.