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510(k) Data Aggregation

K Number

K954594

Device Name

RETICULOCYTE METHOD, RBC INDICES

Manufacturer

BAYER CORP.

Date Cleared

1996-08-23

(325 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Technicon H+3 RTC/RTX reticulocyte method are implied by the reported performance characteristics and the stated goals of the evaluation. While explicit threshold values are not given, the device is considered to meet acceptance criteria if its performance is comparable to established methods (NCCLS for reticulocytes) and demonstrates high correlation and low bias for RBC indices.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Parameter	Implied Acceptance Criteria (e.g., strong correlation, low bias)	Reported Device Performance	Study Type
Reticulocyte Count			Accuracy (vs. Manual Counts)
% retic (r)	High correlation (e.g., >0.90)	0.97	Comparison to NCCLS method
% retic (Slope)	Close to 1 (e.g., 0.9-1.1)	0.93	Comparison to NCCLS method
% retic (Intercept)	Close to 0	0.0	Comparison to NCCLS method
% retic (Syx)	Low error	0.56	Comparison to NCCLS method
% retic (Reference Mean)	Matches H•3 Mean closely	2.0	Comparison to NCCLS method
% retic (H•3 Mean)	Matches Reference Mean closely	1.9	Comparison to NCCLS method
abs retic (10^9^/L) (r)	High correlation (e.g., >0.90)	0.93	Comparison to NCCLS method
abs retic (Slope)	Close to 1 (e.g., 0.9-1.1)	0.86	Comparison to NCCLS method
abs retic (Intercept)	Close to 0	6.4	Comparison to NCCLS method
abs retic (Syx)	Low error	22.6	Comparison to NCCLS method
abs retic (Reference Mean)	Matches H•3 Mean closely	84.9	Comparison to NCCLS method
abs retic (H•3 Mean)	Matches Reference Mean closely	79.1	Comparison to NCCLS method
RBC Indices			Accuracy (vs. H+3 CBC/Diff Mode)
MCV (r)	High correlation (e.g., >0.95)	0.974	Comparison to H+3 CBC/Diff
MCV (Slope)	Close to 1 (e.g., 0.9-1.1)	0.88	Comparison to H+3 CBC/Diff
MCV (Intercept)	Close to 0	10.0	Comparison to H+3 CBC/Diff
MCV (Syx)	Low error	1.0	Comparison to H+3 CBC/Diff
MCV (Bias)	Close to 0	-0.1	Comparison to H+3 CBC/Diff
CHCM (r)	High correlation (e.g., >0.95)	0.988	Comparison to H+3 CBC/Diff
CHCM (Slope)	Close to 1 (e.g., 0.9-1.1)	1.06	Comparison to H+3 CBC/Diff
CHCM (Intercept)	Close to 0	-1.6	Comparison to H+3 CBC/Diff
CHCM (Syx)	Low error	0.7	Comparison to H+3 CBC/Diff
CHCM (Bias)	Close to 0	0.4	Comparison to H+3 CBC/Diff
CH (r)	High correlation (e.g., >0.95)	0.980	Comparison to H+3 CBC/Diff
CH (Slope)	Close to 1 (e.g., 0.9-1.1)	0.95	Comparison to H+3 CBC/Diff
CH (Intercept)	Close to 0	2.0	Comparison to H+3 CBC/Diff
CH (Syx)	Low error	0.6	Comparison to H+3 CBC/Diff
CH (Bias)	Close to 0	0.5	Comparison to H+3 CBC/Diff
RDW (r)	High correlation (e.g., >0.90)	0.937	Comparison to H+3 CBC/Diff
RDW (Slope)	Close to 1 (e.g., 0.9-1.1)	1.06	Comparison to H+3 CBC/Diff
RDW (Intercept)	Close to 0	-0.8	Comparison to H+3 CBC/Diff
RDW (Syx)	Low error	0.5	Comparison to H+3 CBC/Diff
RDW (Bias)	Close to 0	0.1	Comparison to H+3 CBC/Diff
HDW (r)	High correlation (e.g., >0.95)	0.990	Comparison to H+3 CBC/Diff
HDW (Slope)	Close to 1 (e.9., 0.9-1.1)	1.13	Comparison to H+3 CBC/Diff
HDW (Intercept)	Close to 0	-0.25	Comparison to H+3 CBC/Diff
HDW (Syx)	Low error	0.14	Comparison to H+3 CBC/Diff
HDW (Bias)	Close to 0	0.11	Comparison to H+3 CBC/Diff
Precision	Low SD and CV		Within Run Precision
Retic (%) (CV)	Low CV (e.g.,

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