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.

AI/ML Overview

This document describes the performance of the HCL-200 Clinical Chemistry Analyzer, not an AI device. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The HCL-200 Clinical Chemistry Analyzer's performance was evaluated against the predicate device, the Roche COBAS MIRA, using NCCLS (National Committee for Clinical Laboratory Standards) evaluation protocols. The acceptance criteria were not explicitly stated as numerical targets in the provided text. Instead, the study aimed to demonstrate "substantially equivalent performance" to the predicate device. This equivalence was assessed through linearity, precision (simple and complex), and method comparison studies.

The tables below summarize the reported device performance for each evaluated reagent, which served as evidence for meeting the implicit acceptance criteria of substantial equivalence.

Table 1: HCL-200 Reported Linearity & Precision

REAGENT NAME	LINEARITY (Linear Range)	SIMPLE PRECISION (Normal CV / Abnormal CV)	COMPLEX PRECISION (Normal CV / Abnormal CV)
Albumin	2 to 8.5 g/dL	1.8% / 1.7%	8% / 6.4%
ALT (GPT)	0 to 650 U/L	3% / 1.5%	4.6% / 2.1%
Amylase	0 to 2500 U/L	4.6% / 1.7%	5.0% / 3.5%
AST (GOT)	0 to 650 U/L	3.5% / 2.6%	6.1% / 4.6%
Bilirubin, Total	0 to 20 mg/dL	2.8% / 1.5%	7.3% / 9.0%
BUN, Rate	0 to 125 mg/dL	4.1% / 1.9%	5.8% / 5.2%
CK NAD, Imidazole	0 to 2100 U/L	2.3% / 2.3%	4.6% / 2.1%
Creatinine, (Jaffe)	0 to 12.5 mg/dL	2.45% / 1.9%	7.2% / 3.1%
CRP	not applicable	6.3% / 1.9%	6.7% / 2.6%
GGT	5 to 129 mg/dL	2.9% / 1.3%	5.9% / 2.2%
Glucose, Hexokinase UV	0 to 600 mg/dL	2.6% / 2.3%	1.0% / 2.9%
LDH-L	0 to 1000 U/L	2.1% / 0.5%	2.8% / 1.9%
Phosphorus	0 to 15.0 mg/dL	2.9% / 1.2%	5.5% / 3.1%
Total Protein	0 to 12 g/dL	1.6% / 0.9%	2.4% / 1.9%
Triglycerides GPO	0 to 1000 mg/dL	2.8% / 1.6%	4.2% / 3.3%
Uric Acid	0 to 20 mg/dL	1.7% / 1.8%	4.2% / 4.8%

Table 2: HCL-200 Comparison to Predicate Device (COBAS MIRA)

REAGENT NAME	COMPARISON TO PREDICATE (COBAS MIRA)
Albumin	N: 100, Slope [m]: 1.000, Intercept [b]: -0.03, Correlation Coeff. [r]: 0.987
ALT (GPT)	N: 104, Slope [m]: 1.08, Intercept [b]: 0.6, Correlation Coeff. [r]: 0.998
Amylase	N: 101, Slope [m]: 1.09, Intercept [b]: -2.8, Correlation Coeff. [r]: 0.999
AST (GOT)	N: 100, Slope [m]: 1.05, Intercept [b]: -0.6, Correlation Coeff. [r]: 0.997
Bilirubin, Total	N: 100, Slope [m]: 0.902, Intercept [b]: 0.11, Correlation Coeff. [r]: 0.993
BUN, Rate	N: 100, Slope [m]: 0.948, Intercept [b]: 1.1, Correlation Coeff. [r]: 0.996
CK NAD, Imidazole	N: 100, Slope [m]: 1.034, Intercept [b]: 5.6, Correlation Coeff. [r]: 0.999
Creatinine, (Jaffe)	N: 103, Slope [m]: 0.994, Intercept [b]: 0.045, Correlation Coeff. [r]: 0.997
CRP	N: 100, Slope [m]: Not specified, Intercept [b]: Not specified, Correlation Coeff: [r]: 0.992
GGT	N: 100, Slope [m]: 1.07, Intercept [b]: -0.9, Correlation Coeff: [r]: 0.999
Glucose, Hexokinase UV	N: 400, Slope [m]: 0.998, Intercept [b]: 7.5, Correlation Coeff: [r]: 0.992
LDH-L	N: 100, Slope [m]: 1.06, Intercept [b]: 16.2, Correlation Coeff: [r]: 0.992
Phosphorus	N: 111, Slope [m]: 1.06, Intercept [b]: 0.0, Correlation Coeff: [r]: 0.985
Total Protein	N: 102, Slope [m]: 1.05, Intercept [b]: -0.09, Correlation Coeff: [r]: 0.983
Triglycerides GPO	N: 102, Slope [m]: 1.025, Intercept [b]: -2.5, Correlation Coeff: [r]: 0.994
Uric Acid	N: 100, Slope [m]: 1.02, Intercept [b]: -0.25, Correlation Coeff: [r]: 0.987

Study Details:

Sample size used for the test set and the data provenance:
- Linearity (Number [N]):
  - Albumin: 5
  - ALT (GPT): 7
  - Amylase: 9
  - AST (GOT): 6
  - Bilirubin, Total: 6
  - BUN, Rate: 5
  - CK NAD, Imidazole: 8
  - Creatinine, (Jaffe): 5
  - CRP: Not specified
  - GGT: 8
  - Glucose, Hexokinase UV: 5
  - LDH-L: 9
  - Phosphorus: 6
  - Total Protein: 5
  - Triglycerides GPO: 5
  - Uric Acid: 5
- Simple Precision (Number [N]): 20 for all reagents.
- Complex Precision (Number [N]): 80 for all reagents.
- Comparison to Predicate (Number [N]):
  - Albumin: 100
  - ALT (GPT): 104
  - Amylase: 101
  - AST (GOT): 100
  - Bilirubin, Total: 100
  - BUN, Rate: 100
  - CK NAD, Imidazole: 100
  - Creatinine, (Jaffe): 103
  - CRP: 100
  - GGT: 100
  - Glucose, Hexokinase UV: 400
  - LDH-L: 100
  - Phosphorus: 111
  - Total Protein: 102
  - Triglycerides GPO: 102
  - Uric Acid: 100
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, the tests were conducted according to NCCLS evaluation protocols commonly used for in vitro diagnostic devices. This implies lab-based testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study concerns a chemical analyzer, not an AI device relying on expert interpretation of images or clinical data. The "ground truth" for these tests would be the established reference methods of the predicate device (COBAS MIRA) and calibrated controls/standards used in analytical chemistry.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is a measurement device, not an AI system requiring human adjudication of its output.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The HCL-200 is a "discrete random access in vitro diagnostic multichannel chemistry analyzer." The performance reported is that of the instrument itself (standalone performance) under laboratory control. There is no human-in-the-loop for the analytical process of measuring chemical concentrations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is established clinical chemistry standards, controls, and comparisons to a legally marketed predicate device (Roche COBAS MIRA). The predicate device's measurements serve as the reference standard against which the HCL-200's results are compared.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" in this context refers to optimizing application parameters for the reagents on the instrument after a "two-week device familiarization period." This is more akin to calibration and method development.
How the ground truth for the training set was established: Not applicable, as there's no traditional "training set" for AI. The process described is "Preliminary evaluations using NCCLS EP 10 - T2 were run on each reagent in order to optimize application parameters." This involves using laboratory standards and controls to ensure the instrument's methods are correctly set up and calibrated for each assay.

Summary

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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.

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Substantial Equivalence and Summary Performance Data:

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:

Table 3 NCCLS Protocols Used in Evaluation/ Comparison
NCCLS Document Number	Document Title
EP 10 - T2Vol. 13 No, 10	Preliminary Evaluation of Quantitative ClinicalLaboratory Methods, Second Edition
EP6-PVol. 6 No. 18	Evaluation of the Linearity of QuantitativeAnalytical Methods
EP5 - T2Vol. 12, No.4	Evaluation of Precision Performance of ClinicalChemistry Devices, Second Edition
EP9 - TVol. 13 No. 4	Method Comparison and Bias Estimation UsingPatient 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 TOPREDICATE (COBAS MIRA)
Albumin	K831585	CRP	K902593	Albumin	Number [N]: 5Linear Range:2 TO 8.5 g/dL	Number [N]: 20Normal: CV: 1.8%Abnormal CV: 1.7%	Number [N]: 80Normal: CV: 8%Abnormal CV: 6.4%	Number [N]: 100Slope [m]: 1.000Intercept [b]: -0.03Correlation Coeff. [r]: 0.987
ALT (GPT)	K820525	GGT	K905085	ALT (GPT)	Number [N]: 7Linear Range:0 to 650 U/L	Number [N]: 20Normal: CV: 3%Abnormal CV: 1.5%	Number [N]: 80Normal: CV: 4.6%Abnormal CV: 2.1%	Number [N]: 104Slope [m]: 1.08Intercept [b]: 0.6Correlation Coeff. [r]: 0.998
Amylase	K861718	Glucose, HexokinaseUV	K801765	Amylase	Number [N]: 9Linear Range:0 to 2500 U/L	Number [N]: 20Normal: CV: 4.6%Abnormal CV: 1.7%	Number [N]: 80Normal: CV: 5.0%Abnormal CV: 3.5%	Number [N]: 101Slope [m]: 1.09Intercept [b]: -2.8Correlation Coeff. [r]: 0.999
AST (GOT)	K820270	LDH-L	K822312	AST (GOT)	Number [N]: 6Linear Range:0 to 650 U/L	Number [N]: 20Normal: CV: 3.5%Abnormal CV: 2.6%	Number [N]: 80Normal: CV: 6.1%Abnormal CV: 4.6%	Number [N]: 100Slope [m]: 1.05Intercept [b]: -0.6Correlation Coeff. [r]: 0.997
Bilirubin, Total	K841892	Phosphorus	K870776	Bilirubin, Total	Number [N]: 6Linear Range:0 to 20 mg/dL	Number [N]: 20Normal: CV: 2.8%Abnormal CV: 1.5%	Number [N]: 80Normal: CV: 7.3%Abnormal CV: 9.0%	Number [N]: 100Slope [m]: 0.902Intercept [b]: 0.11Correlation Coeff. [r]: 0.993
BUN, Rate	K812417	Total Protein	K841466	BUN, Rate	Number [N]: 5Linear Range:0 to 125mg/dL	Number [N]: 20Normal: CV: 4.1%Abnormal CV: 1.9%	Number [N]: 80Normal: CV: 5.8%Abnormal CV: 5.2%	Number [N]: 100Slope [m]: 0.948Intercept [b]: 1.1Correlation Coeff. [r]: 0.996
CK NAD, Imidazole	K905084/A	Triglycerides GPO	K842029/A	CK NAD, Imidazole	Number [N]: 8Linear Range:0 to 2100 U/L	Number [N]: 20Normal: CV: 2.3%Abnormal CV: 2.3%	Number [N]: 80Normal: CV: 4.6%Abnormal CV: 2.1%	Number [N]: 100Slope [m]: 1.034Intercept [b]: 5.6Correlation Coeff. [r]: 0.999
Creatinine, (Jaffe)	K840872	Uric Acid	K812641	Creatinine, (Jaffe)	Number [N]: 5Linear Range:0 to 12.5 mg/dL	Number [N]: 20Normal: CV: 2.45%Abnormal CV: 1.9%	Number [N]: 80Normal: CV: 7.2%Abnormal CV: 3.1%	Number [N]: 103Slope [m]: 0.994Intercept [b]: 0.045Correlation Coeff. [r]: 0.997

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

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HCL Laboratory Systems, Inc.

510(k) Notification for HCL -200

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트

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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]: 20Normal: CV: 6.3%Abnormal CV:1.9%	Number [N]: 80Normal: CV: 6.7%Abnormal CV: 2.6%	Number [N]: 100Slope [m]:Intercept [b]:Correlation Coeff: [r]: 0.992
GGT	Number [N]: 8Linear Range:5 to 129 mg/dL	Number [N]: 20Normal: CV: 2.9%Abnormal CV: 1.3%	Number [N]: 80Normal: CV: 5.9%Abnormal CV:2.2%	Number [N]: 100Slope [m]: 1.07Intercept [b]: -0.9Correlation Coeff: [r]: 0.999
Glucose, Hexokinase UV	Number [N]: 5Linear Range:0 to 600 mg/dL	Number [N]: 20Normal: CV: 2.6%Abnormal CV: 2.3%	Number [N]: 80Normal: CV: 1.0%Abnormal CV: 2.9%	Number [N]: 400Slope [m]:0.998Intercept [b]: 7.5Correlation Coeff: [r]: 0.992
LDH-L	Number [N]: 9Linear Range:0 to 1000 U/L	Number [N]: 20Normal: CV: 2.1%Abnormal CV: 0.5%	Number [N]: 80Normal: CV: 2.8%Abnormal CV: 1.9%	Number [N]: 100Slope [m]: 1.06Intercept [b]: 16.2Correlation Coeff: [r]: 0.992
Phosphorus	Number [N]: 6Linear Range:0 to 15.0 mg/dL	Number [N]: 20Normal: CV: 2.9%Abnormal CV: 1.2%	Number [N]: 80Normal: CV: 5.5%Abnormal CV: 3.1%	Number [N]: 111Slope [m]: 1.06Intercept [b]: 0.0Correlation Coeff: [r]: 0.985
Total Protein	Number [N]: 5Linear Range:0 to 12 g/dL	Number [N]: 20Normal: CV: 1.6%Abnormal CV: 0.9%	Number [N]: 80Normal: CV: 2.4%Abnormal CV: 1.9%	Number [N]: 102Slope [m]: 1.05Intercept [b]: -0.09Correlation Coeff: [r]: 0.983
Triglycerides GPO	Number [N]: 5Linear Range:0 to 1000 mg/dL	Number [N]: 20Normal: CV: 2.8%Abnormal CV: 1.6%	Number [N]: 80Normal: CV: 4.2%Abnormal CV: 3.3%	Number [N]: 102Slope [m]: 1.025Intercept [b]: -2.5Correlation Coeff: [r]: 0.994
Uric Acid	Number [N]: 5Linear Range:0 to 20 mg/dL	Number [N]: 20Normal: CV: 1.7%Abnormal CV: 1.8%	Number [N]: 80Normal: CV: 4.2%Abnormal CV: 4.8%	Number [N]: 100Slope [m]: 1.02Intercept [b]: -0.25Correlation Coeff: [r]: 0.987

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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.

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.